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 | K160426 |
| 510k Number | K160426 |
| Device Name: | Syngo.via MI Workflows |
| Classification | System, Image Processing, Radiological |
| Applicant | SIEMENS MEDICAL SOLUTIONS USA, INC. 2501 NORTH BARRINGTON RD. Hoffman Estates, IL 60192 |
| Contact | Veronica Padharia |
| Correspondent | Veronica Padharia SIEMENS MEDICAL SOLUTIONS USA, INC. 2501 NORTH BARRINGTON RD. 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 | 2016-02-16 |
| Decision Date | 2016-03-04 |
| Summary: | summary |