The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Syngo.via Mi Workflows.
| Device ID | K163421 |
| 510k Number | K163421 |
| Device Name: | Syngo.via MI Workflows |
| Classification | System, Image Processing, Radiological |
| Applicant | Siemens Medical Solutions USA, Inc. 810 Innovation Drive Knoxville, TN 37932 |
| Contact | Veronica Padharia |
| Correspondent | Veronica Padharia Siemens Medical Solutions USA, Inc. 810 Innovation Drive Knoxville, TN 37932 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-12-06 |
| Decision Date | 2017-01-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056869041070 | K163421 | 000 |
| 04056869041063 | K163421 | 000 |
| 04056869041056 | K163421 | 000 |
| 04056869041049 | K163421 | 000 |
| 04056869041032 | K163421 | 000 |