K120246 is an FDA 510(k) clearance for the KODAK DIRECTVIEW CR MAMMOGRAPHY SYSTEM (USING CARESTREAM CR MAMMOGRAPHY CASSETTE WITH SNP-M1 SCREEN). This device is classified as a Full Field Digital, System, X-ray, Mammographic (Class II - Special Controls, product code MUE).
Submitted by Carestream Health, Inc. (Rochester, US). The FDA issued a Cleared decision on August 28, 2012, 214 days after receiving the submission on January 27, 2012.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1715.
| 510(k) Number | K120246 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 27, 2012 |
| Decision Date | August 28, 2012 |
| Days to Decision | 214 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | MUE — Full Field Digital, System, X-ray, Mammographic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1715 |