The following data is part of a premarket notification filed by Siemens Healthcare Gmbh with the FDA for Syngo.via (version Vb40a).
| Device ID | K191040 |
| 510k Number | K191040 |
| Device Name: | Syngo.via (Version VB40A) |
| Classification | System, Image Processing, Radiological |
| Applicant | Siemens Healthcare GmbH Siemensstr. 1 Forchheim, DE 91301 |
| Contact | Elango Alampalayam Rangappan |
| Correspondent | Georg Bauer 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 | 2019-04-19 |
| Decision Date | 2019-05-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056869247953 | K191040 | 000 |
| 04056869237633 | K191040 | 000 |
| 04056869259802 | K191040 | 000 |
| 04056869285801 | K191040 | 000 |