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 | K211379 |
| 510k Number | K211379 |
| Device Name: | Syngo.via RT Image Suite |
| Classification | System, Planning, Radiation Therapy Treatment |
| 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 | MUJ |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-05-04 |
| Decision Date | 2021-07-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056869267425 | K211379 | 000 |