Approval for the kodak directview cr mammography system. The device is indicated for the kodak directview cr mammography feature together with kodak directview cr mammography cassette comprise a device which, when used in conjunction with a kodak directview cr system and a mammographic x-ray machine, generates digital mammographic images that can be used for screening and diagnosis of breast cancer. It is intended for use in the same clinical applications as traditional screen-film based mammographic systems. The mammographic images can be interpreted by a qualified physician using either hardcopy film or softcopy display at a workstation.
| Device | KODAK DIRECTVIEW COMPUTED RADIOGRAPHY (CR) MAMMOGRAPHY |
| Generic Name | Full Field Digital, System, X-ray, Mammographic |
| Applicant | CARESTREAM HEALTH, INC. |
| Date Received | 2008-07-28 |
| Decision Date | 2010-11-03 |
| Notice Date | 2010-11-23 |
| PMA | P080018 |
| Supplement | S |
| Product Code | MUE |
| Docket Number | 10M-0591 |
| Advisory Committee | Radiology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | CARESTREAM HEALTH, INC. 150 Verona Street rochester, NY 14608 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P080018 | | Original Filing |
| S001 |
2010-11-03 |
Normal 180 Day Track |
NIH GUDID Devices