The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc with the FDA for Mammomat Fusion With Stereotactic Biopsy.
| Device ID | K163252 |
| 510k Number | K163252 |
| Device Name: | Mammomat Fusion With Stereotactic Biopsy |
| Classification | Full Field Digital, System, X-ray, Mammographic |
| Applicant | SIEMENS MEDICAL SOLUTIONS USA, INC 40 Liberty Boulevard, Mail Code 65-1A Malvern, PA 19355 |
| Contact | Denise Adams |
| Correspondent | Denise Adams SIEMENS MEDICAL SOLUTIONS USA, INC 40 Liberty Boulevard, Mail Code 65-1A Malvern, PA 19355 |
| Product Code | MUE |
| CFR Regulation Number | 892.1715 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-18 |
| Decision Date | 2017-01-10 |
| Summary: | summary |