Syngo.plaza
System, Image Processing, Radiological
Siemens Healthcare GmbH
The following data is part of a premarket notification filed by Siemens Healthcare Gmbh with the FDA for Syngo.plaza.
Pre-market Notification Details
| Device ID | K180563 |
| 510k Number | K180563 |
| Device Name: | Syngo.plaza |
| Classification | System, Image Processing, Radiological |
| Applicant | Siemens Healthcare GmbH Henkestrasse 127 Erlangen, DE 91502 |
| Contact | Vijay Ramadas |
| Correspondent | Alexander Schapovalov TUV SUD AMERICA INC. 1775 OLD HIGHWAY 8 NW New Brighton, MN 55112 -1891 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2018-03-05 |
| Decision Date | 2018-04-25 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056869096506 | K180563 | 000 |
Trademark Results [Syngo.plaza]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SYNGO.PLAZA 79073973 3785042 Live/Registered |
Siemens Healthcare GmbH 2009-06-30 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.