The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Syngo.via Mi Workflows, Scenium, Syngo Mbf.
| Device ID | K211459 |
| 510k Number | K211459 |
| Device Name: | Syngo.via MI WorkFlows, Scenium, Syngo MBF |
| Classification | Automated Radiological Image Processing Software |
| Applicant | Siemens Medical Solutions USA, Inc. 810 Innovation Drive Knoxville, TN 37932 |
| Contact | Clayton Ginn |
| Correspondent | Clayton Ginn Siemens Medical Solutions USA, Inc. 810 Innovation Drive Knoxville, TN 37932 |
| Product Code | QIH |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-05-11 |
| Decision Date | 2021-06-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056869279800 | K211459 | 000 |