Other products from "ICAD, INC."
No Primary DI Version or Model Catalog Number Device Description Product Code Product Code Name Device Class Brand Name
1 00858012005922 V3.4 D70141, D70142, D70160 "PowerLook Density Assessment 3.4 is a software application intended for use wit "PowerLook Density Assessment 3.4 is a software application intended for use with DBT 2D images from tomosynthesis exams. PowerLook Density Assessment 3.4 provides a BI-RADS 5th Edition breast density category to aid health care professionals in the assessment of breast tissue composition. PowerLook Density Assessment 3.4 produces adjunctive information. It is not a diagnostic aid.  LLZ System, Image Processing, Radiological 2 PowerLook Density Assessment V3.4
2 00858012005854 V7.2 DSC017-04-US The SecondLook Computer-Aided Detection (CAD) system for mammography is intended The SecondLook Computer-Aided Detection (CAD) system for mammography is intended to identify and mark regions of interest on screening and diagnostic mammograms from full-field digital mammography (FFDM) systems to bring them to the attention of the radiologist after an initial reading has been completed. Thus the system prompts the radiologist to areas on mammograms for second review only. MYN Analyzer,Medical Image 2 Powerlook PRO with SLD, GE, US
3 00858012005748 720823 F5410-30 Packaged Cutout 30mm, xFlex KPY Shield, Protective, Personnel 1 Packaged Cutout 30mm, xFlex
4 00858012005649 711110 SK1050 Surface Applicator Cone, 50mm JAD System, Therapeutic, X-Ray 2 Surface Applicator Cone, 50 mm
5 00858012005601 V7.2 DSC017-01-US The SecondLook Computer-Aided Detection (CAD) system for mammography is intended The SecondLook Computer-Aided Detection (CAD) system for mammography is intended to identify and mark regions of interest on screening and diagnostic mammograms from full-field digital mammography (FFDM) systems to bring them to the attention of the radiologist after an initial reading has been completed. Thus the system prompts the radiologist to areas on mammograms for second review only. MYN Analyzer,Medical Image 2 PowerLook AMP PRO with SecondLook Digital
6 00858012005496 720269 AG3030 Vaginal Applicator 30 mm JAD System, Therapeutic, X-Ray 2 Vaginal Applicator, 30mm
7 00858012005410 720297 SK3510 Surface Applicator End Cap, 10 mm, 10-Pack JAD System, Therapeutic, X-Ray 2 (10) Applicator End Cap, 10 mm
8 00858012005373 710707 F5350-4 Rigid Shield 4 cm JAD System, Therapeutic, X-Ray 2 Rigid Shield 4 cm
9 00858012005342 720343 AB2063E Balloon Applicator, 5x7 cm Ellipsodial JAD System, Therapeutic, X-Ray 2 Balloon Applicator Kit
10 00858012005335 720332 AB2062 Balloon Applicator, 5-6 cm Spherical JAD System, Therapeutic, X-Ray 2 Balloon Applicator Kit
11 00858012005328 720331 AB2061 Balloon Applicator, 4-5 cm Spherical JAD System, Therapeutic, X-Ray 2 Balloon Applicator Kit
12 00858012005311 720342 AB2060 Balloon Applicator, 3-4 cm Spherical JAD System, Therapeutic, X-Ray 2 Balloon Applicator Kit
13 00858012005250 V1.1 DSC014-02-EU The iCAD PowerLook® Tomo Detection Software is a computer-assisted detection (CA The iCAD PowerLook® Tomo Detection Software is a computer-assisted detection (CAD) software device intended to be used concurrently by radiologists while reading GE digital breast tomosynthesis exams. The system detects up to five soft tissue densities (masses, architectural distortions and asymmetries) in the 3D tomosynthesis images. The detections are blended with the standard 2D synthetic image and the CAD-enhanced 2D synthetic image is viewed on a mammography review workstation. The CAD-enhanced 2D synthetic image assists radiologists in identifying densities (masses, architectural distortions and asymmetries) that may be confirmed or dismissed by the radiologist in the digital breast tomosynthesis (DBT) images. MYN Analyzer,Medical Image 2 PowerLook PRO Tomo Detection and SLD, GE
14 00858012005236 V1.1 DSC014-01-EU The iCAD PowerLook® Tomo Detection Software is a computer-assisted detection (CA The iCAD PowerLook® Tomo Detection Software is a computer-assisted detection (CAD) software device intended to be used concurrently by radiologists while reading GE digital breast tomosynthesis exams. The system detects up to five soft tissue densities (masses, architectural distortions and asymmetries) in the 3D tomosynthesis images. The detections are blended with the standard 2D synthetic image and the CAD-enhanced 2D synthetic image is viewed on a mammography review workstation. The CAD-enhanced 2D synthetic image assists radiologists in identifying densities (masses, architectural distortions and asymmetries) that may be confirmed or dismissed by the radiologist in the digital breast tomosynthesis (DBT) images. MYN Analyzer,Medical Image 2 PowerLook PRO Tomo Detection and SLD, GE
15 00858012005229 V1.1 DSC014-01-US The iCAD PowerLook® Tomo Detection Software is a computer-assisted detection (CA The iCAD PowerLook® Tomo Detection Software is a computer-assisted detection (CAD) software device intended to be used concurrently by radiologists while reading GE digital breast tomosynthesis exams. The system detects up to five soft tissue densities (masses, architectural distortions and asymmetries) in the 3D tomosynthesis images. The detections are blended with the standard 2D synthetic image and the CAD-enhanced 2D synthetic image is viewed on a mammography review workstation. The CAD-enhanced 2D synthetic image assists radiologists in identifying densities (masses, architectural distortions and asymmetries) that may be confirmed or dismissed by the radiologist in the digital breast tomosynthesis (DBT) images. MYN Analyzer,Medical Image 2 PowerLook PRO Tomo Detection and SLD, GE
16 00858012005205 V2.1 D70124, D70141 and D70126 PowerLook Density Assessment is a software application intended for use with dig PowerLook Density Assessment is a software application intended for use with digital mammographysystems. PowerLook Density Assessment calculates breast density as a ratio of fibroglandular tissue andtotal breast area estimates. PowerLook Density Assessment provides these numerical values for eachbreast as well as a density category to aid radiologists in the assessment of breast tissuecomposition. PowerLook Density Assessment produces adjunctive information. It is not an interpretive ordiagnostic aid. LLZ System, Image Processing, Radiological 2 iReveal Breast Density Assessment
17 00858012005168 DSC010-08 MYN Analyzer, Medical Image 2 PowerLook AMP SLD Planmed
18 00850008977237 DSC018-07 LMD System, Digital Image Communications, Radiological 1 PowerLook PRO+ 4GPU Tower Platform, US
19 00850008977190 DSC012-03 LLZ System, Image Processing, Radiological 2 PowerLook AMP with Density Assessment GE OUS
20 00850008977084 DSC011-03-US LMD System, Digital Image Communications, Radiological 1 PowerLook 10 PRO+, Rack Mount, US
21 00858012005960 2.1 QDQ Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicio Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer 2 ProFound AI
22 00858012005823 V7.2 DSC017-03-ROW The SecondLook Computer-Aided Detection (CAD) system for mammography is intended The SecondLook Computer-Aided Detection (CAD) system for mammography is intended to identify and mark regions of interest on screening and diagnostic mammograms from full-field digital mammography (FFDM) systems to bring them to the attention of the radiologist after an initial reading has been completed. Thus the system prompts the radiologist to areas on mammograms for second review only. MYN Analyzer,Medical Image 2 Powerlook PRO Hardware Upgrade, SLD
23 00858012005809 V7.2 DSC017-02-ROW The SecondLook Computer-Aided Detection (CAD) system for mammography is intended The SecondLook Computer-Aided Detection (CAD) system for mammography is intended to identify and mark regions of interest on screening and diagnostic mammograms from full-field digital mammography (FFDM) systems to bring them to the attention of the radiologist after an initial reading has been completed. Thus the system prompts the radiologist to areas on mammograms for second review only. MYN Analyzer,Medical Image 2 Powerlook PRO Hardware Upgrade, SLD
24 00858012005793 V7.2 DSC017-02-US The SecondLook Computer-Aided Detection (CAD) system for mammography is intended The SecondLook Computer-Aided Detection (CAD) system for mammography is intended to identify and mark regions of interest on screening and diagnostic mammograms from full-field digital mammography (FFDM) systems to bring them to the attention of the radiologist after an initial reading has been completed. Thus the system prompts the radiologist to areas on mammograms for second review only. MYN Analyzer,Medical Image 2 Powerlook PRO Hardware Upgrade, SLD
25 00858012005588 720772 F5201 Flexishield Radiation Absorber, Box KPY Shield, Protective, Personnel 1 Flexishield Radiation Absorber
26 00858012005694 720818 F5410-15 Packaged Cutout 15 mm, xFlex KPY Shield, Protective, Personnel 1 Packaged Cutout 15 mm, xFlex
27 00858012005526 750850 XP1200 Axxent Surface Controller JAD System, Therapeutic, X-Ray 2 Axxent Surface Controller
28 00858012005519 750050 XP1100 Axxent Standard Controller JAD System, Therapeutic, X-Ray 2 Axxent Standard Controller
29 00858012005403 710710 F5350-7 Rigid Shield 7 cm JAD System, Therapeutic, X-Ray 2 Rigid Shield 7 cm
30 00858012005304 720697 S7551 Axxent HDR X-Ray Source 50 cm HUT JAD System, Therapeutic, X-Ray 2 HDR X-ray Source 2.2
31 00858012005298 720684-02 S7601 Axxent HDR X-Ray Source 25 cm ESL JAD System, Therapeutic, X-Ray 2 HDR X-ray Source 2.2
32 00858012005281 720684 S7501 Axxent HDR X-Ray Source 25 cm HUT JAD System, Therapeutic, X-Ray 2 HDR X-ray Source 2.2
33 00858012005243 V1.1 DSC014-02-US The iCAD PowerLook® Tomo Detection Software is a computer-assisted detection (CA The iCAD PowerLook® Tomo Detection Software is a computer-assisted detection (CAD) software device intended to be used concurrently by radiologists while reading GE digital breast tomosynthesis exams. The system detects up to five soft tissue densities (masses, architectural distortions and asymmetries) in the 3D tomosynthesis images. The detections are blended with the standard 2D synthetic image and the CAD-enhanced 2D synthetic image is viewed on a mammography review workstation. The CAD-enhanced 2D synthetic image assists radiologists in identifying densities (masses, architectural distortions and asymmetries) that may be confirmed or dismissed by the radiologist in the digital breast tomosynthesis (DBT) images. MYN Analyzer,Medical Image 2 PowerLook PRO with Tomo Detection, Upgrade, GE
34 00858012005175 DSC010-09 MYN Analyzer, Medical Image 2 PowerLook AMP SLD Agfa CR
35 00858012005113 DSC010-03-EU MYN Analyzer, Medical Image 2 PowerLook AMP SLD Siemens OUS
36 00850008977145 DSC018-06 LMD System, Digital Image Communications, Radiological 1 PowerLook PRO+ Rack-Mount, US
37 00850008977244 DSC018-07-UP LMD System, Digital Image Communications, Radiological 1 PowerLook PRO+ 4GPU Tower Upgrade, US
38 00850008977121 DSC018-04 LMD System, Digital Image Communications, Radiological 1 PowerLook PRO+ Hardware Platform GE, US
39 00858012005939 V2 QDQ Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicio Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer 2 PowerLook Tomo Detection (ProFound AI)
40 00858012005861 V7.2 D4D0192 The SecondLook Computer-Aided Detection (CAD) system for mammography is intended The SecondLook Computer-Aided Detection (CAD) system for mammography is intended to identify and mark regions of interest on screening and diagnostic mammograms from full-field digital mammography (FFDM) systems to bring them to the attention of the radiologist after an initial reading has been completed. Thus the system prompts the radiologist to areas on mammograms for second review only. MYN Analyzer,Medical Image 2 Powerlook PRO with SLD, FRU
41 00858012005762 720825 F5410-KIT Packaged Cutout set,xFlex KPY Shield, Protective, Personnel 1 Packaged Cutout set,xFlex
42 00858012005731 720822 F5410-27 Packaged Cutout 27 mm, xFlex KPY Shield, Protective, Personnel 1 Packaged Cutout 27 mm, xFlex
43 00858012005717 720820 F5410-22 Packaged Cutout 22.2 mm, xFlex KPY Shield, Protective, Personnel 1 Packaged Cutout 22.2 mm, xFlex
44 00858012005595 710339 SK1000 Surface Applicator Set JAD System, Therapeutic, X-Ray 2 Surface Applicator Set
45 00858012005472 720267 AG3020 Vaginal Applicator 20 mm JAD System, Therapeutic, X-Ray 2 Vaginal Applicator, 20mm
46 00858012005427 720298 SK3520 Surface Applicator End Cap, 20 mm, 10-Pack JAD System, Therapeutic, X-Ray 2 (10) Applicator End Cap, 20 mm
47 00858012005274 710706 F5350-3 Rigid Shield 3 cm JAD System, Therapeutic, X-Ray 2 Rigid Shield 3 cm
48 00858012005212 V1.1 DS0244, D70130 The iCAD PowerLook® Tomo Detection Software is a computer-assisted detection (CA The iCAD PowerLook® Tomo Detection Software is a computer-assisted detection (CAD) software device intended to be used concurrently by radiologists while reading GE digital breast tomosynthesis exams. The system detects up to five soft tissue densities (masses, architectural distortions and asymmetries) in the 3D tomosynthesis images. The detections are blended with the standard 2D synthetic image and the CAD-enhanced 2D synthetic image is viewed on a mammography review workstation. The CAD-enhanced 2D synthetic image assists radiologists in identifying densities (masses, architectural distortions and asymmetries) that may be confirmed or dismissed by the radiologist in the digital breast tomosynthesis (DBT) images. MYN Analyzer,Medical Image 2 PowerLook Tomo Detection Software
49 00858012005090 DSC010-01-EU MYN Analyzer, Medical Image 2 PowerLook AMP SLD GE OUS
50 00858012005083 V7.2 2376858-8-US The SecondLook Computer-Aided Detection (CAD) system for mammography is intended The SecondLook Computer-Aided Detection (CAD) system for mammography is intended to identify and mark regions of interest on screening and diagnostic mammograms from full-field digital mammography (FFDM) systems to bring them to the attention of the radiologist after an initial reading has been completed. Thus the system prompts the radiologist to areas on mammograms for second review only.Field Replacement System MYN Analyzer,Medical Image 2 PowerLook AMP SLD FRU GE
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No Primary DI Version or Model Catalog Number Device Description Brand Name Organization Name
1 00196852162192 VCA01B Videa Caries Assist is a computer-assisted detection (CADe) device that analyzes Videa Caries Assist is a computer-assisted detection (CADe) device that analyzes intraoral radiographs to identify and localize carious lesions.Videa Caries Assist is indicated for the review of bitewing (BW) radiographs acquired from adult patients aged 22 years or older. Videa Caries Assist VIDEAHEALTH, INC.
2 B630QVCSIK1010344 10.10-3.4.4 Installation Kit for QVCAD System Release 3.4.4 with Debian 10.10 QVCAD System Installation Kit QVIEW MEDICAL
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12 M994MVU10500 1050 The M-Vu Algorithm Engine is a Computer-Aided Detection (CAD) software device in The M-Vu Algorithm Engine is a Computer-Aided Detection (CAD) software device intended to aid radiologists in reading mammograms. It is a proprietary software application designed to process digitized film mammograms and digital mammograms. The mammogram images are automatically analyzed to mark areas for review by a radiologist. Results are displayed on either a mammography workstation, high resolution monitor, or printed case report. M-Vu Algorithm Engine VUCOMP, INC.
13 M760ACCFFDM00170 7.0 ACCFFDM00170 Parascript® AccuDetect® is a Computer-Aided Detection (CAD) software device inte Parascript® AccuDetect® is a Computer-Aided Detection (CAD) software device intended to aid radiologists reading mammograms. It is a proprietary software application designed to process FFDM images. The digital mammography images are automatically analyzed to identify areas suspicious for possible soft tissue densities and/or calcifications. Results are displayed on a computer monitor for review by a radiologist. The radiologist is instructed to first review each case in the conventional manner and then re-examine the case utilizing the information supplied by the Parascript® AccuDetect system before making a final assessment for the case.AccuDetect® is not a diagnostic device, as the CAD marks are intended to be used to assist only in detection and not in interpretation. Therefore, AccuDetect® can assist a radiologist in detecting areas of concern that would have been missed without its use, but if used properly it cannot cause a radiologist to miss areas of concern that would have been detected without AccuDetect®. Parascript® AccuDetect® PARASCRIPT, LLC
14 M760ACCFFDM00161 6.1 ACCFFDM00161 Parascript® AccuDetect® is a Computer-Aided Detection (CAD) software device inte Parascript® AccuDetect® is a Computer-Aided Detection (CAD) software device intended to aid radiologists reading mammograms. It is a proprietary software application designed to process FFDM images. The digital mammography images are automatically analyzed to identify areas suspicious for possible soft tissue densities and/or calcifications. Results are displayed on a computer monitor for review by a radiologist. The radiologist is instructed to first review each case in the conventional manner and then re-examine the case utilizing the information supplied by the Parascript® AccuDetect system before making a final assessment for the case.AccuDetect® is not a diagnostic device, as the CAD marks are intended to be used to assist only in detection and not in interpretation. Therefore, AccuDetect® can assist a radiologist in detecting areas of concern that would have been missed without its use, but if used properly it cannot cause a radiologist to miss areas of concern that would have been detected without AccuDetect®. Parascript® AccuDetect® PARASCRIPT, LLC
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