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 | K201444 |
| 510k Number | K201444 |
| Device Name: | Syngo.via RT Image Suite |
| Classification | System, Planning, Radiation Therapy Treatment |
| Applicant | Siemens Medical Solutions USA, Inc. 2501 N Barrington Rd. Hoffman Estate, IL 60192 |
| Contact | Cynthia Busch |
| Correspondent | Cynthia Busch Siemens Medical Solutions USA, Inc. 2501 N Barrington Rd. Hoffman Estate, 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 | 2020-06-01 |
| Decision Date | 2020-08-13 |