Breast Tomosynthesis Systems

Company Name Fujifilm Medical Systems U.S.A. Inc. Hologic Hologic

Product name ASPIRE Cristalle 3Dimensions Mammography System with Clarity HD high-resolution 3D imaging, Intelligent 2D imaging technology and SmartCurve Breast Stabilization System Selenia Dimensions (3000/6000/9000) and Genius 3D Mammography exams
FDA cleared, year ASPIRE Cristalle 2014; ASPIRE Cristalle with Tomosynthesis 2017 3Dimensions FDA approved 2017, Clarity HD high-resolution 3D imaging and Intelligent 2D imaging technology FDA approved 2018 FDA PMA for tomosynthesis February 2011
FDA indication of equivalent/superior to Superior to FFDM Superior to FFDM Superior to FFDM
FFDM
FDA approved indications for use The Fujifilm ASPIRE Cristalle system acquires and generates 2-D and 3-D images and is intended for use in the screening and diagnosis of breast cancer; each The Hologic 3Dimensions system generates digital mammographic images that can be used for screening and diagnosis of breast cancer; the 3Dimensions (2-D or 3-D) system is intended for use in the same clinical applications as a 2-D mammography system for screening mammograms; specifically, the 3Dimensions system can be used to generate 2-D digital mammograms and 3-D mammograms; each screening
screening examination may consist of CC and MLO views from: a 2-D FFDM image set, or a 2-D and 3-D image set, where the 2-D image can be either a FFDM or a 2-D examination may consist of: a 2-D FFDM image set, or a 2-D and 3-D image set, where the 2-D image can be either a FFDM or a 2-D image generated from the 3-D image set; the 3Dimensions system may also be used for additional diagnostic workup of the breast
image generated from the 3-D image set
CE mark, year N/S 2017 September 2008
What differentiates your product from Innovative hexagonal close pattern (HCP) detector yields more efficient capture vs. conventional square pixels, resulting in lower patient dose; Intelligent Automatic 3Dimensions system is a fast, high resolution breast tomosynthesis system; the system matches the unrivaled performance of our Genius 3-D Mammography exam, which is more accurate than conventional 2-D mammograms, detecting 20-65% more invasive breast cancers. Improvements transform the patient experience without compromising on speed or accuracy: designed to improve visibility of fine details for greater
competitors Exposure Control (iAEC) provides intelligent auto recognition of differentiating tissues, muscle and implants for optimal exposure conditions diagnostic confidence; curved compression surface that mirrors the shape of the breast, for a more even compression improves the patient experience; smart positioning in the MLO position; robust, yet natural looking 2D image generated from high resolution 3D data delivers superior performance at a low dose compared to 2D alone; extended field light for biopsy procedures; new stationary gantry controls improve
ergonomics and technologist workflow; clarity HD high-resolution 3D imaging enables high-resolution 3D imaging in 3.7 seconds; new grid assembly increases system reliability and uptime; new optional Intelligent 2D technology generates comprehensive, natural-looking synthesized 2D image from the 3D data to enhance subtle mammographic features and lesion morphology
Number of WW installs N/S Over 6,000
Scan angle 15 degrees 15 degrees 15 degrees
Z Plane resolution N/S N/S N/S
Binning used in tomosynthesis N/S Standard res: Yes; with Clarity HD: no Standard res: Yes; with Clarity HD: no
Detetor resolution for tomosynthesis N/S Standard res: 100 _m; with Clarity HD: 70 _m Standard res: 100 _m; with Clarity HD: 70 _m
(with binning if used)
Scan time, 60 mm breast <4 sec 3.7 seconds (using Intelligent 2D software) 3.7 seconds (using C-View software)
Tomo dose for ACR phantom 1.38 mGy 1.45 mGy 1.45 mGy
Combo (Tomo + 2D) dose for ACR 1.38 mGy (using S-View software) 1.45 mGy (using Intelligent 2D software) 1.45 mGy (using C-View software)
phantom
Upgrade from FFDM (hardware/software ASPIRE Cristalle software only; ASPIRE HD or HD-plus full system replacement Hardware and software upgrade S/w upgrade
required)
Tomo require add-on unit or built in? Built in Built in - tomo only system Built in
Reconstruction time for 60 mm breast N/S <5 seconds <5 seconds
Tomo-guided breast biopsy available? Not yet available in U.S. Yes Yes
Size of tomo screening paddles 18 x 24 and 24 x 30 Various paddles available; no limit; 18 x 24 cm, 24 x 30 cm, small breast paddle, etc. Various paddles available; no limit; 18 x 24 cm, 24 x 30 cm, small breast paddle, etc.
Tomo with needle localization paddles No Yes Yes
supported?
Combo mode imaging supported? Yes Yes Yes
Compression time for combo study, 60 N/S ~10 sec. (from initial compression to end of X-ray exposure) ~10 sec. (from initial compression to end of X-ray exposure)
mm breast
PACS requirements MG, BTO DICOM objects: MG, DBT, SC, GSPS; DICOM functions: Q/R, DICOM store, DICOM send, DICOM, store commit DICOM objects: MG, DBT, SC, GSPS; DICOM functions: Q/R, DICOM store, DICOM send, DICOM, store commit
Generator type High frequency High frequency High frequency
kV range 22 - 49 in 1 kV increments 20 - 49 kVp 20 - 49 kVp
mAs Range 2 - 600 3 - 150 mAs 3 - 150 mAs
mA range 20 - 200 10- 200 mA 10- 200 mA
AEC detector Automatic, semi-automatic, manual Yes; both AutoAEC and manually select AEC regions Yes; both AutoAEC and manually select AEC regions
Parameters controlled Automatic mode (including for implants): kV, mAs, target/filter, grid, AEC, dose; semi manual and full manual modes also available kVp, mAs, filter, AEC method, AEC location kVp, mAs, filter, AEC method, AEC location
Breast Density and Dose Reporting
Density reporting software (list if it is Optional VolparaDensity Hologic Quantra breast density assessment included as standard, fully integrated on the acquisition workstation Hologic Quantra breast density assessment software available as optional license on the acquisition
optional or integrated and who is the workstation
software vendor)
Breast density score correlating to BIRADS 5th edition Breast density score compliant with BI-RADS fifth edition; density scores per patient and per breast Breast density score compliant with BI-RADS fifth edition; density scores per patient and per breast
Breast density score correlating to BIRADS 5th edition; volume of fibroglandular tissue, volume of breast, volumetric breast density (%) Breast density score compliant with BI-RADS fifth edition Breast density score compliant with BI-RADS fifth edition
Dose software record dose Calculated AGD is recorded in the DICOM header Advanced connectivity license Advanced connectivity license
How is density information stored or Structured Report DICOM Structured Report and Secondary Capture; also available as report on acquisition workstation DICOM Structured Report and Secondary Capture; also available as report on acquisition workstation
transferred
Digital Detector
Type (CCD, CsI, aSe) aSe direct-conversion aSe aSe
Spatial resolution Detection: equivalent 68um; image output 50 um (2-D), 100 um (tomo) 70 _m; FFDM resolution: 70 _m; tomo resolution: 85 _m 70 _m; FFDM resolution: 70 _m; tomo resolution: 85 _m
Matrix, pixels 24 x 30 cm: 4,728 x 5,928 = 28,027,584 pixels 3,328 x 4,096 3,328 x 4,096
Standard size 24 x 30 3,328 x 4,096 3,328 x 4,096
High-resolution size 24 x 30 3,328 x 4,096 3,328 x 4,096
Imaging area: Standard size, cm 24 x 30 24 x 29 cm 24 x 29 cm
Imaging area: High-resolution size, cm 24 x 30 24 x 29 cm 24 x 29 cm
Additional Features (space permitting) Innovative hexagonal close pattern (HCP) pixel design engineered to deliver higher acquisition efficiency for finer detail, higher DQE, higher MTF and lower dose than Supports dual energy imaging; selenium based direct capture technology Supports dual energy imaging; selenium based direct capture technology
conventional square pixel arrays; dose control via intelligent AEC, including full automatic mode for implant imaging
Acquisition Workstation
Workstation Yes Yes Yes
Monitor size, inches 21.3 in (3 MP) Imaging monitor: 21.3 (2 MP/3 MP); control monitor: 17 in. Imaging monitor: 21.3 (2 MP/3 MP); control monitor: 17 in.
Hard disk capacity 500 GB or higher 1 TB (min.) 1 TB (min.)
Memory 8 GB or higher 16 GB RAM (min) 16 GB RAM (min)
Networking capabilities Ethernet; DICOM + IHE compliant Ethernet Ethernet
Adjustable height N/S Available Available
Multiple exposure control options Yes Yes Yes
Gray levels 14 bit 10 bit display 10 bit display
Additional features (space permitting) DVIIm image processing provides improved contrast and density stability throughout the entire 2-D exposure region and achieves improved visibility across a wide Upgrade features available for enhanced ergonomics Upgrade features available for enhanced ergonomics
range of breast compositions including the presence of implants; workstation meets requirements of multiple IHE profiles including: Mammography Acquisition
Workflow (MAWF), Mammography Image Profile (MAMMO), Scheduled Workflow Profile (SWF), Portable Data for Imaging Profile (PDI)
Review Workstation
Workstation BellusII SecurView DX SecurView DX
Monitor size, inches Dependant on customer requirements High contrast dual 5 Megapixel 21.3 in. LCD display with built-in auto-calibration and 10 bit graphics card; single 12 Megapixel 33.6 in. LCD display with built-in auto-calibration and 10 bit graphics card; standard dual 5 Megapixel 21.3 in. LCD display with 10 bit graphics card High contrast dual 5 Megapixel 21.3 in. LCD display with built-in auto-calibration and 10 bit graphics card; single
12 Megapixel 33.6 in. LCD display with built-in auto-calibration and 10 bit graphics card; standard dual 5
Megapixel 21.3 in. LCD display with 10 bit graphics card
Hard disk capacity Dependant on customer requirements Minimum 3.5 TB, RAID 5, disk encryption Minimum 3.5 TB, RAID 5, disk encryption
Memory Dependant on customer requirements 16GB High Speed RAM Minimum 16GB High Speed RAM Minimum
Networking capabilities Dependant on customer requirements 10/100/1,000 Base T Ethernet 10/100/1,000 Base T Ethernet
Archive/storage Dependant on customer requirements SecurXchange archive SecurXchange archive
Type Dependant on customer requirements Departmental PACS Departmental PACS
Capacity Dependant on customer requirements At least 3 TB At least 3 TB
Gray levels N/S N/S N/S
Additional features (space permitting) Dedicated breast imaging support tools including Intellilink crossreferencing of CC/MLO images, corridor view/image masking, integrated report function and CAD Meets the requirements of IHE Radiology Mammography Image Integration Profile- Image Display Actor; capable of accepting DICOM BTO, CT, SCO Meets the requirements of IHE Radiology Mammography Image Integration Profile- Image Display Actor;
support; customizable reading protocols, keypad, keyboard and mouse controls capable of accepting DICOM BTO, CT, SCO
X-Ray Tube
Anode type Tungsten Tungsten Tungsten
Heat capacity, HU 300,000 300,00 HU 300,00 HU
Heat dissipation rate, HU / min. 60,000 60 kHU/min 60 kHU/min
Target/filter combinations W/Rh Tungsten/aluminim Tungsten/aluminim
Focal spot size, mm 0.1 mm and 0.3 mm 0.3 mm 0.3 mm
Positioning Assembly
Collimation Yes N/S N/S
Tracking of collimation during the tomo N/S N/S N/S
scan
18 x 24 cm Yes Yes Yes
24 x 30 cm Yes Yes Yes
MovementlLocks Electromagnetic Electro-magnetic brakes Electro-magnetic brakes
Assembly movement N/S N/S N/S
-190 to +190 +180 degress to -140 degrees (total rotation) +180 degress to -140 degrees (total rotation)
Vertical, cm (inches) 69-150 (27.2-59.1) 70 cm- 141 cm (28.3- 55 in.) 70 cm- 141 cm (28.3- 55 in.)
SID, cm 65 70 cm 70 cm
Scale guide N for force and mm for thickness Yes, lb or N Yes, lb or N
Handswitch Yes (customer option) No No
Radiation Output
mR / Sec. @ 28 kVp N/S 1,232 mR/sec @ 28 kVp (0.7 mm Al filter) 1,232 mR/sec @ 28 kVp (0.7 mm Al filter)
Radiation Shield
L x W, cm (inches) 108 x 60.4 (42.5 x 24) 84 W x 138 L cm 84 W x 138 L cm
Thickness 0.5 mm Pb equivalent 12 mm leaded acrylic, 0.5 mm Pb/ 35 kV per IEC 60601-2-45 12 mm leaded acrylic, 0.5 mm Pb/ 35 kV per IEC 60601-2-45
Compression system Auto and manual compression N/S N/S
Force, Newtons 0-200 Manual: max 300 N; pre-compression force: 67 to 134 N; full range compression force: 89 to 178 N Manual: max 300 N; pre-compression force: 67 to 134 N; full range compression force: 89 to 178 N
Grid ratio 6:1 41 lines/cm N/A for tomo N/A for tomo
Bucky N/A for tomo N/A for tomo N/A for tomo
Magnification device 1.8x (for 2-D) N/A for tomo N/A for tomo
Stereotactic device Optional Affirm Affirm
Film ID system N/A None None
Label printer N/A None None
Power requirements 200/208/220/230/240V Gantry: 2080/208/220230/240 VAC; AWS: 100/120/200/208/220/230/240 VAC Gantry: 2080/208/220230/240 VAC; AWS: 100/120/200/208/220/230/240 VAC
H x W x D, cm (inches) H 197.4 cm (77in.) W 62.4 cm (24.57 in.) x D 127.4 cm (50 in.) Gantry: 66 W (26 in.) x 223 H (87.8 in.) x 138 D cm (54.25 in.); AWS: 135.6 W (53.4 in.) x 204 H (80.3 in.) x 122 D cm (48.4 in.) Gantry: 66 W (26 in.) x 223 H (87.8 in.) x 138 D cm (54.25 in.); AWS: 135.6 W (53.4 in.) x 204 H (80.3 in.) x 122 D
cm (48.4 in.)
Weight, kg (lb) 370 kg (815.7 lb) Gantry: 400 kg (882 lbs); AWS: 209 kg (460 lbs) Gantry: 400 kg (882 lbs); AWS: 209 kg (460 lbs)
Optional accessories Comfort paddle designed for an improved patient experience; the unique design adapts to the natural breast shape; allowing gradual, more even application of pressure Optional accessories for gantry include but are not limited to biopsy add-on (Affirm), paddles, mag stand, tomo face shield Optional accessories for gantry include but are not limited to biopsy add-on (Affirm), paddles, mag stand, tomo
to the breast compared to traditional paddle designs; biopsy unit, various compression paddles (including spot, mag and small breast paddles), mag table, choice of face shield
decorative stand wraps
Warranty 1 year 12 months 12 months

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