The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Mammomal Inspiration.
| Device ID | K122286 |
| 510k Number | K122286 |
| Device Name: | MAMMOMAL INSPIRATION |
| Classification | Full Field Digital, System, X-ray, Mammographic |
| Applicant | SIEMENS MEDICAL SOLUTIONS USA, INC. 51 VALLEY STREAM PKWY. Malvern, PA 19355 -1406 |
| Contact | Patricia D Jones |
| Correspondent | Patricia D Jones SIEMENS MEDICAL SOLUTIONS USA, INC. 51 VALLEY STREAM PKWY. Malvern, PA 19355 -1406 |
| Product Code | MUE |
| CFR Regulation Number | 892.1715 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-07-30 |
| Decision Date | 2013-02-22 |
| Summary: | summary |