The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Syngo.via Rt Image Suite.
| Device ID | K192065 |
| 510k Number | K192065 |
| Device Name: | Syngo.Via RT Image Suite |
| Classification | System, Planning, Radiation Therapy Treatment |
| Applicant | Siemens Medical Solutions USA, Inc. 2501 N Barrington Rd. Hoffman Estates, IL 60192 |
| Contact | Veronica Padharia |
| Correspondent | Veronica Padharia Siemens Medical Solutions USA, Inc. 2501 N Barrington Rd. Hoffman Estates, IL 60192 |
| Product Code | MUJ |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-08-01 |
| Decision Date | 2019-09-18 |
| Summary: | summary |