MAMMOVISTA B.smart
System, Image Processing, Radiological
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 Mammovista B.smart.
Pre-market Notification Details
| Device ID | K212621 |
| 510k Number | K212621 |
| Device Name: | MAMMOVISTA B.smart |
| Classification | System, Image Processing, Radiological |
| Applicant | Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355 |
| Contact | Martin Rajchel |
| Correspondent | Martin Rajchel Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-18 |
| Decision Date | 2021-11-12 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056869955575 | K212621 | 000 |
| 04056869281230 | K212621 | 000 |
Trademark Results [MAMMOVISTA B.smart]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MAMMOVISTA B.SMART 79317787 not registered Live/Pending |
Siemens Healthcare GmbH 2021-06-18 |
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