Syngo®.via (version VB10A)

System, Image Processing, Radiological

Siemens AG

The following data is part of a premarket notification filed by Siemens Ag with the FDA for Syngo®.via (version Vb10a).

Pre-market Notification Details

• Device ID: K150843
• 510k Number: K150843
• Device Name: Syngo®.via (version VB10A)
• Classification: System, Image Processing, Radiological
• Applicant: Siemens AG Henkestrasse 127 Eriangen, DE 91052
• Contact: Martin Meyer
• 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: Abbreviated
• 3rd Party Reviewed: Yes
• Combination Product: No
• Date Received: 2015-03-30
• Decision Date: 2015-04-24
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04056869123646	K150843	000
04056869106212	K150843	000
04056869084725	K150843	000
04056869054964	K150843	000
04056869054957	K150843	000
04056869040134	K150843	000
04056869020891	K150843	000
04056869020884	K150843	000
04056869007045	K150843	000