Approval for the icad powerlook® tomo detection software is a computer-assisted detection (cad) software device intended to be used concurrently by radiologists while reading ge senoclaire 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.
| Device | PowerLook® Tomo Detection Software |
| Classification Name | Analyzer, Medical Image |
| Generic Name | Analyzer, Medical Image |
| Applicant | ICAD Inc |
| Date Received | 2016-04-05 |
| Decision Date | 2017-03-24 |
| Notice Date | 2017-03-29 |
| PMA | P160009 |
| Supplement | S |
| Product Code | MYN |
| Docket Number | 17M-1950 |
| Advisory Committee | Radiology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | iCAD Inc 98 Spitbrook Road, Suite 100 nashua, NH 03062 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P160009 | | Original Filing |
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NIH GUDID Devices