The following data is part of a premarket notification filed by Siemens Healthcare Gmbh with the FDA for Syngo Dynamics Version Va30.
| Device ID | K171053 |
| 510k Number | K171053 |
| Device Name: | Syngo Dynamics Version VA30 |
| Classification | System, Image Processing, Radiological |
| Applicant | Siemens Healthcare GmbH Henkestrasse 127 Erlangen, DE 91052 |
| Contact | Lauren Bentley |
| 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 | 2017-04-10 |
| Decision Date | 2017-06-01 |
| Summary: | summary |