The following data is part of a premarket notification filed by Siemens Medical Soultions Usa, Inc. with the FDA for Syngo.via Mi Workflows Vb40a, Scenium.
| Device ID | K191309 |
| 510k Number | K191309 |
| Device Name: | Syngo.via MI Workflows VB40A, Scenium |
| Classification | System, Image Processing, Radiological |
| Applicant | Siemens Medical Soultions USA, Inc. 2501 N. Barrington Road Hoffman Estates, IL 60192 |
| Contact | Veronica Padharia |
| Correspondent | Veronica Padharia Siemens Medical Soultions USA, Inc. 2501 N. Barrington Road Hoffman Estates, IL 60192 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-05-14 |
| Decision Date | 2019-07-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056869243405 | K191309 | 000 |
| 04056869243399 | K191309 | 000 |
| 04056869243382 | K191309 | 000 |
| 04056869243375 | K191309 | 000 |
| 04056869243368 | K191309 | 000 |
| 04056869243351 | K191309 | 000 |