The following data is part of a premarket notification filed by Siemens Healthcare Gmbh with the FDA for Syngo®.via Protoneo (version Va20).
| Device ID | K173378 | 
| 510k Number | K173378 | 
| Device Name: | Syngo®.via ProtoNeo (Version VA20) | 
| Classification | System, Image Processing, Radiological | 
| Applicant | Siemens Healthcare GmbH Henkestrasse 127 Erlangen, DE 91052 | 
| Contact | Abhineet Johri | 
| Correspondent | Dawn M Tibodeau 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 | 2017-10-30 | 
| Decision Date | 2017-11-20 | 
| Summary: | summary | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  SYNGO  76166029  2623451 Live/Registered | SIEMENS HEALTHCARE GMBH 2000-11-15 |