The following data is part of a premarket notification filed by Carestream Health,inc. with the FDA for Kodak Directview Cr Mammography System (using Carestream Cr Mammography Cassette With Snp-m1 Screen).
| Device ID | K120246 |
| 510k Number | K120246 |
| Device Name: | KODAK DIRECTVIEW CR MAMMOGRAPHY SYSTEM (USING CARESTREAM CR MAMMOGRAPHY CASSETTE WITH SNP-M1 SCREEN) |
| Classification | Full Field Digital, System, X-ray, Mammographic |
| Applicant | CARESTREAM HEALTH,INC. 150 VERONA STREET Rochester, NY 14608 |
| Contact | Katherine Honsinger |
| Correspondent | Katherine Honsinger CARESTREAM HEALTH,INC. 150 VERONA STREET Rochester, NY 14608 |
| Product Code | MUE |
| CFR Regulation Number | 892.1715 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-01-27 |
| Decision Date | 2012-08-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 60889978215201 | K120246 | 000 |
| 60889971978608 | K120246 | 000 |
| 60889971941503 | K120246 | 000 |