MAMMOMAT Revelation
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 Revelation.
Pre-market Notification Details
| Device ID | K193166 |
| 510k Number | K193166 |
| Device Name: | MAMMOMAT Revelation |
| Classification | Full Field Digital, System, X-ray, Mammographic |
| Applicant | Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard, 65-1A Malvern, PA 19355 |
| Contact | Martin Rajchel |
| Correspondent | Martin Rajchel Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard, 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 | 2019-11-15 |
| Decision Date | 2020-06-12 |
Trademark Results [MAMMOMAT Revelation]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MAMMOMAT REVELATION 79226429 5651984 Live/Registered |
Siemens Healthcare GmbH 2017-12-15 |
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