Nano-x Imaging Ltd.

April 1, 2021
℅ Rafael Aguila
Responsible Third-Party Official
Accelerated Device Approval Services
6800 S.W. 40th Street, Ste. 403
LUDLUM FL 33155

Re: K203782
Trade/Device Name: Nanox Cart X-ray System
Regulation Number: 21 CFR 892.1720
Regulation Name: Mobile x-ray system
Regulatory Class: Class II
Product Code: IZL
Dated: March 1, 2021
Received: March 24, 2021

Dear Rafael Aguila:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced
above and have determined the device is substantially equivalent (for the indications for use stated in the
enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the
enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance
with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a
premarket approval application (PMA). You may, therefore, market the device, subject to the general
controls provisions of the Act. Although this letter refers to your product as a device, please be aware that
some cleared products may instead be combination products. The 510(k) Premarket Notification Database
located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination
product submissions. The general controls provisions of the Act include requirements for annual registration,
listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and
adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We
remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be
subject to additional controls. Existing major regulations affecting your device can be found in the Code of
Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements
concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA
has made a determination that your device complies with other requirements of the Act or any Federal
statutes and regulations administered by other Federal agencies. You must comply with all the Act's
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for

U.S. Food & Drug Administration

10903 New Hampshire Avenue Doc ID# 04017.04.23
Silver Spring, MD 20993
www.fda.gov
K203782 - Rafael Aguila Page 2

devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-
combination-products); good manufacturing practice requirements as set forth in the quality systems (QS)
regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for
combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-
542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part
807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part
803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-
mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including
information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-
devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn
(https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the
Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See
the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-
assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE
by email ([email protected]) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For
Thalia T. Mills, Ph.D.
Director
Division of Radiological Health
OHT7: Office of In Vitro Diagnostics
and Radiological Health
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure
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 Nanox Cart X-Ray System – 510(k)
Submission File
Nano-x Imaging Ltd.
Neve Ilan Communication Center, Zip 9085000, Israel
Telephone: +972-2-574-6300

510(k) Summary K203782

Applicant: Nano-x Imaging Ltd.

Neve Ilan Communications Center
Jerusalem District
Israel, 9085000
Phone: +972 (2) 574-6300

Contact Person: Yuval Shapiro

QA/RA
Nano-x Imaging Ltd.
Phone: +972 (54) 205-2524
Email: [email protected]

Date Prepared: Mar. 1, 2021

Device Trade Name: Nanox Cart X-Ray System

Device Common Name: Mobile X-Ray Device
Classification Name: Mobile X-Ray system
Regulation Number: 21 CFR 892.1720
Regulation Class: II
Product Code: IZL

Predicate Device: AMX-4 Mobile X-Ray System

Manufacturer: GE Medical Systems
510(k) Number: K021016
Regulation Name: Mobile x-ray system
Number: 21 CFR 892.1720
Regulatory Class: II
Product Code: IZL

Reference Device: DRX-Revolution Nano Mobile X-ray System

Manufacturer: Carestream Health Inc.
510(k) Number: K173924
Regulation Name: Mobile x-ray system
Number: 21 CFR 892.1720
Regulatory Class: II
Product Code: IZL

Page 1 of 8
 Nanox Cart X-Ray System – 510(k)
Submission File
Nano-x Imaging Ltd.
Neve Ilan Communication Center, Zip 9085000, Israel
Telephone: +972-2-574-6300

Device Description:

The Nanox Cart X-Ray system is a mobile X-Ray system designed to perform radiographic X-Ray
examinations of hands, wrists, and fingers, on adult patients. The system facilitates X-ray
examinations in situations where it is not possible or feasible to transport the patient to a ward
with fixed equipment.
The Nanox Cart X-Ray system consists of a mobile system enclosure; an X-Ray tube assembly
consists of the X-ray Tube, Cooling Fluid, electronics, and casing; a pulse generator and a high-
voltage generator; a microprocessor that provides increased exposure consistency and efficient
operation; and a touch-based screen LCD which provides a simple and user-friendly interface and
technique selection.
The Nanox Cart is specified and designed to operate only with a Flat Panel Digital X-ray Detector
Model EVS3643, manufactured by DRTECH Inc. (K162552)

The intended operators of the Nanox Cart X-ray System are healthcare professionals familiar
with and responsible for the X-ray examinations being performed.

To minimize electrical, mechanical, and radiation hazards, the Nanox Cart X-ray System adheres
to recognized and established industry practices and standards.

Intended Use/Indications for Use:

The product is intended as an X-Ray source for diagnosis. Operators of the Nano-x Cart X-Ray System are
healthcare professionals familiar with and responsible for the X-Ray examinations being performed.

Indication for Use – The device is designed to perform radiographic X-Ray examinations of hands, wrists,
and fingers, on adult patients.

Limitations for use – This device is not intended for general radiographic X-Ray examinations other than
the indicated use, or for mammographic, angiographic, interventional, or fluoroscopic applications. This
device is not intended for pediatric use.

Summary of Technology Characteristics:

Table 1 provides a comparison of the technological characteristics for the Nanox Cart X-Ray System and
the predicate device.
Table 2 provides a comparison of the technological characteristics for the Nanox Cart X-Ray System and
the reference device.

Page 2 of 8
 Nanox Cart X-Ray System – 510(k)
Submission File
Nano-x Imaging Ltd.
Neve Ilan Communication Center, Zip 9085000, Israel
Telephone: +972-2-574-6300

Table 1: Comparison of Technological Characteristics

Nanox Cart X-Ray System AMX-4 Mobile X-Ray System Significant

(K203782( (K021016) Difference
Regulatory
510(k) K203782 K0210161
Device class II II Same
ClassificationMobile x-ray system, Class II; Mobile x-ray system, Class II; 21 Same
21 CFR 892.1720 CFR 892.1720
Product code IZL IZL Same
Indications / The device is designed to The AMX-4 Plus Mobile X-ray Similar
Intended use perform radiographic X-Ray System is indicated for use in
examinations of hands, wrists, generating radiographic images of
and fingers, on adult patients. human anatomy in all general-
purpose X-ray diagnostic procedures.
It may be used in radiology
departments, emergency rooms,
intensive care units, operating rooms,
pediatrics, orthopedics, and clinics.

Intended X-ray Technicians trained to X-ray Technicians trained to operate Same

users operate the system the system
Physical Characteristics
System The Nanox Cart X-Ray System The AMX-4mobile X-ray system is Similar
Components is comprised of the following comprised of the following
components: components:
1) Cart
1) Cart – The mobile 2) Collimator
enclosure of the system. 3) Column
2) Wheels and Breaks – Set 4) Power Connectors
of 4 (four) wheels and 5) Rotating Arm
integral breaks that are 6) Docking tube and docking
placed to enable the receiver
mobility of the cart and 7) E-Stop (Emergency Stop)
have a stationary knobs
positioning during 8) Grid alignment system
operation (cart will not be 9) PREP/EXP switch
operated during movement). 10) Screen
3) On/Off Switch – A switch 11) Tube head assembly
that switches the system on. 12) X-Ray Tube
4) X-Ray Stop (Emergency
Stop) – An emergency stop

1
https://www.accessdata.fda.go, v/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K021016

Page 3 of 8
 Nanox Cart X-Ray System – 510(k)
Submission File
Nano-x Imaging Ltd.
Neve Ilan Communication Center, Zip 9085000, Israel
Telephone: +972-2-574-6300

Nanox Cart X-Ray System AMX-4 Mobile X-Ray System Significant

(K203782( (K021016) Difference
that prevents the system
from operating, should the
operator determine to halt
procedure.
5) X-Ray Switch – A switch
that enables the X-ray
radiation energy.
6) Display – Operators display
of energy emitted by the
Nanox Cart. The display is
a touchscreen that enables
adjusting the energy pulse
(touchscreen) from 0.1mAs
up to 2mAs in steps of
0.1mAs.
7) Controller – the Display
and a micro-controller
(Arduino Mega 256)
controls the Nanox Cart X-
ray System's functionality
and GUI display.
8) Pulse Generator – The
pulse generator enables a
pulse of 40kVp and 0.1—
2mAs.
9) Isolation Transformer –
Enables protection from
power mains surges.
10) Power Supply – Power
mains input of
230VAC/50Hz/300W.
11) Tube Assembly – The X-
ray tube assembly consists
of the X-ray Tube, Cooling
Fluid, electronics, and
casing to enable the
emission of the radiation
energy.
12) X-ray Tube – Nano-x's
Cold Cathode tube.
Imaging The Nanox Cart is specified and Any commercially available Different
Radiographic designed to operate only with a Radiographic film cassette
film cassette Flat Panel Digital X-ray

Page 4 of 8
 Nanox Cart X-Ray System – 510(k)
Submission File
Nano-x Imaging Ltd.
Neve Ilan Communication Center, Zip 9085000, Israel
Telephone: +972-2-574-6300

Nanox Cart X-Ray System AMX-4 Mobile X-Ray System Significant

(K203782( (K021016) Difference
Detector Model EVS3643,
manufactured by DRTECH Inc.
(K162552)

Technology
Principles of The positions of the Tube The technician has the ability to Different
Operation Assembly and detector holder position the AMX-4's tube assembly
are prefixed. The technician using the rotating arm. The AMX-4
positions the patient's hand is an all-inclusive device, where X-
inside the indicated irradiation ray images are constructed on its
area on the detector. Display.
The technician sets the required The AMX-4 has a rechargeable array
energy on the Display's of 12.9V batteries that has the ability
touchscreen. Irradiation energy to operate the following methods:
is set with a fixed radiographic 1. Two 70 kVp, 10 mAs X−ray
output voltage of 40kVp and a exposures, >7 seconds of
variable charge of 0.1—2mAs. preparation, > 25 seconds of field
Exposure time varies from light, 5 minutes of drive time, 9
50ms up-to 1s (non-selectable). minutes of idle time
Once energy is set, the 2. The AMX 4 batteries will provide
technician operates the system enough capacity for 165 or more 100
by pressing the X-Ray switch. kVp, 100 mAs X−ray exposures.
Each exposure includes 4 seconds of
preparation time and 30 seconds of
idle time for battery recovery. This
number may be reduced by
additional idle time required for
X−ray tube cooling.
System Same
240 VAC, 50 Hz 100/200 VAC, 50/60 Hz
Power
Battery Different
No Yes
Powered
kV Range 40 kVp 50-125 kVp, in 24 steps Different
mAs Range 0.1 to 2mAs, in 0.1mAs step 0.40 to 320 mAs, in 30 steps Different
Tube Similar
Nanox Tube GE X-Ray tube model HRT09
Type/Model
Focal Spot 0.3 mm 0.6/2.0 mm Similar
Target Angle 0 degrees 15 degrees Similar
Column Different
Rotation Fixed (+/-)270 degrees
Range

Page 5 of 8
 Nanox Cart X-Ray System – 510(k)
Submission File
Nano-x Imaging Ltd.
Neve Ilan Communication Center, Zip 9085000, Israel
Telephone: +972-2-574-6300

Nanox Cart X-Ray System AMX-4 Mobile X-Ray System Significant

(K203782( (K021016) Difference
Max Speed Similar
4 4.8
(kph)
Horizontal Different
Fixed 40.6
Travel (cm)
Vertical Different
Fixed 138.4
Travel (cm)
Maximum Different
40 kV 100 kV
Tube Voltage
Aperture Same
Rectangular Rectangular
shape
Aperture Different
Fixed Operator Adjustable
Control

Table 2: Subject and Reference Device (DRX-Revolution Nano X-ray system) Comparison

Nanox Cart X-Ray System DRX-Revolution Nano Significant

(K203782( X-ray system Difference
Regulatory
510(k) K203782 K173924
Device class II II Same
Classification Mobile x-ray system, Class II; Mobile x-ray system, Class II; 21 CFR Same
21 CFR 892.1720 892.1720
Product code IZL IZL Same
Indications / The device is designed to The device is designed to perform Similar
Intended use perform radiographic X-Ray radiographic x-ray examinations on
examinations of hands, wrists, pediatric and adult patients, in all
and fingers, on adult patients. patient treatment areas.
Intended X-ray Technicians trained to X-ray Technicians trained to operate Same
users operate the system the system
Technology
System Power 240 VAC, 50 Hz 100 – 240 V, 50/60 Hz Same
Power output 0.08kW Maximum 4.8 kW @ 104 msec and Similar
7.7 kW @ 13 msec of power
Nominal 40kVp 40 kVp to 110 kVp Similar
Voltage
Output
Nominal mAs 0.1/2mAs 0.2 mAs to 20 mAs Similar
kV Range Fixed: 40 kVp 40 kVp to 110 kVp different
mAs Range 0.1 to 2mAs, in 0.1mAs step 0.2 to 20.0 mAs Similar
Tube Nanox Tube Xinray CNT Tube Similar
Type/Model

Page 6 of 8
 Nanox Cart X-Ray System – 510(k)
Submission File
Nano-x Imaging Ltd.
Neve Ilan Communication Center, Zip 9085000, Israel
Telephone: +972-2-574-6300

Tube Weight 0.4 kg 1.1 kg Similar

Focal Spot 0.3 mm 0.9 mm to 1.9 mm Different
Target Angle 16 deg 14deg Similar

Performance Data
Bench testing
The complete system has been assessed and tested at the factory and by Standards testing facilities. The
System passed all predetermined testing criteria. The Validation Test Plan was designed to evaluate all
input functions, output functions, and actions performed by Nano-x, and followed the process
documented in the System Validation Test Plan. Nonclinical testing results are provided in the 510(k).
Validation testing indicated that as required by the risk analysis, designated individuals performed all
verification and validation activities and that the results demonstrated that the predetermined
acceptance criteria were met.

The following Standards were used to test the System, has met all the requirements listed in the Standards
except for inapplicable requirements (which are listed in the various test reports):
• Nanox Cart X-Ray System Verification testing
• Software verification and validation (ISO 62304:2006 + A1:2015)
• Preclinical Comparison Tests
• Ergonomic testing (IEC60601-1-6, IEC62366)
• Electrical Safety Testing (IEC 60601-1, IEC 62304:2006 + A1:2014)
• Electromagnetic Compatibility (IEC 60601-1-2 Ed. 4)
• IEC/EN 60601-1: 2005 + AMD1: 2012 (3.1 Ed.) Medical electrical equipment – Part 1: General
requirements for basic safety and essential performance.
• IEC 60601-1-2: 2014 Medical electrical equipment - Part 1-2: General requirements for basic
safety and essential performance - Collateral Standard: Electromagnetic disturbances -
Requirements and tests.
• IEC 60601-1-3: 2008 + AMD1: 2013 Medical electrical equipment - Part 1-3: General requirements
for basic safety and essential performance - Collateral Standard: Radiation protection in
diagnostic X-ray equipment
• IEC 60601-2-28:2017 Medical electrical equipment - Part 2-28: Particular requirements for the
basic safety and essential performance of X-ray tube assemblies for medical diagnosis
• IEC 60601-2-54:2009+AMD1:2015+AMD2:2018 Medical electrical equipment - Part 2-54:
Particular requirements for the basic safety and essential performance of X-ray equipment for
radiography and radioscopy

in accordance with section 514(c)(1)(A) of the FD&C Act as outlined in "Medical X-ray Imaging Devices:
Conformance with IEC Standards," dated May 2019.

Page 7 of 8
 Nanox Cart X-Ray System – 510(k)
Submission File
Nano-x Imaging Ltd.
Neve Ilan Communication Center, Zip 9085000, Israel
Telephone: +972-2-574-6300

The diagnostic imaging performance of the Nanox Cart X-Ray system was evaluated by executing a
phantom imaging study. The phantoms used for the imaging study were commercial products
manufactured by Kyoto Kagaku and intended for X-Ray imaging tests. The phantoms represent different
hands and are anthropomorphic both in appearance, size, and X-Ray attenuation characteristics.

Performance output shows that the Nanox Cart is capable of supplying X-Rays to generate radiographies.
Professional evaluation of the output and professional comparison between the Nanox Cart X-Ray system
and predicate device’s output demonstrate that the outcome images of the Nanox Cart X-Ray system are
as good as an X-Ray system available in market. Based on the clinical evaluations of three experts it can
be concluded that the Nanox Cart X-Ray system operates as intended and generates images that are as
good as images produced by the predicate Device.

Clinical testing
Nano-x Imaging Ltd. does not believe that clinical data is necessary to support the determination that the
Nanox Cart X-ray System is substantially equivalent to the predicate. The bench testing described above
is very comprehensive and demonstrates that the system meets its performance specifications.
Specifically, the bench testing demonstrated the ability of the system to emit X-ray radiation as
determined in its specifications.

The testing demonstrated that the product meets its performance specifications and performs as
intended. In addition, the Nanox Cart X-Ray System was found to be substantially equivalent to the
predicate device as it has the same indications for use and compliance with similar standards.

Substantial Equivalence Discussion:

The indications for use for the predicate device are similar to the proposed indications for use for the
Nanox Cart X-Ray System. The technical characteristics of the System are not different from the predicate
device except for the fixed Source-to-image Distance, Field of view, aperture, focal spot size, and the fixed
Tube voltage and reduced maximum exposure current-time product. As demonstrated in Table 1 above,
any differences in the technological characteristics do not raise any questions of safety or effectiveness.

The generated X-ray beams by both devices are the same, resulting with similar images generated by the
devices. Thus, rendering the Nanox Cart X-Ray System substantially equivalent to the predicate device.

Conclusions
Extensive bench testing was conducted, which demonstrated that the Nanox Cart X-Ray System meets its
performance specifications. This collection of testing demonstrates the safety and effectiveness of the
Nanox Cart X-Ray System and its substantial equivalence to the predicate device.

Page 8 of 8