The following data is part of a premarket notification filed by Siemens Ag, Medical Solutions with the FDA for Syngo.via.
Device ID | K123920 |
510k Number | K123920 |
Device Name: | SYNGO.VIA |
Classification | System, Image Processing, Radiological |
Applicant | SIEMENS AG, MEDICAL SOLUTIONS HENKESTRASSE 127 Erlangen, DE 91052 |
Contact | Sabine Schroedel |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2012-12-20 |
Decision Date | 2013-01-18 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
04056869033686 | K123920 | 000 |
04056869033679 | K123920 | 000 |
04056869020976 | K123920 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
SYNGO.VIA 79073846 3811150 Live/Registered |
Siemens Healthcare GmbH 2009-09-01 |