K828055 is an FDA 510(k) clearance for the MAMMOMAT B AND BE..
Submitted by Siemens Medical Solutions USA, Inc. (Issaquah, US). The FDA issued a Cleared decision on September 29, 1982, 30 days after receiving the submission on August 30, 1982.
This device falls under the Radiology FDA review panel.
| 510(k) Number | K828055 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 30, 1982 |
| Decision Date | September 29, 1982 |
| Days to Decision | 30 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | — |
| Product Code | — |
| Device Class | — |