MAMMOMAT Fusion
Full Field Digital, System, X-ray, Mammographic
Siemens Medical Solutions USA, Inc.
The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Mammomat Fusion.
Pre-market Notification Details
| Device ID | K151645 |
| 510k Number | K151645 |
| Device Name: | MAMMOMAT Fusion |
| Classification | Full Field Digital, System, X-ray, Mammographic |
| Applicant | Siemens Medical Solutions USA, Inc. 51 Valley Stream Parkway Malvern, PA 19355 |
| Contact | Darren Dorman |
| Correspondent | Darren Dorman Siemens Medical Solutions USA, Inc. 51 Valley Stream Parkway 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 | 2015-06-18 |
| Decision Date | 2015-09-14 |
| Summary: | summary |
Trademark Results [MAMMOMAT Fusion]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MAMMOMAT FUSION 79151942 4705995 Live/Registered |
Siemens Healthcare GmbH 2014-08-07 |
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