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 |