K021113 is an FDA 510(k) clearance for the MAMMOPATH. This device is classified as a Cabinet, X-ray System (Class II - Special Controls, product code MWP).
Submitted by Fischer Imaging Corp. (Denver, US). The FDA issued a Cleared decision on June 13, 2002, 69 days after receiving the submission on April 5, 2002.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1680.
| 510(k) Number | K021113 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 05, 2002 |
| Decision Date | June 13, 2002 |
| Days to Decision | 69 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Statement |
| Product Code | MWP — Cabinet, X-ray System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1680 |