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 | K162370 |
| 510k Number | K162370 |
| Device Name: | Syngo.via RT Image Suite |
| Classification | System, Planning, Radiation Therapy Treatment |
| Applicant | Siemens Medical Solutions USA, Inc. 40 Liberty Blvd., Mail Code 65-1A Malvern, PA 19355 |
| Contact | Kimberly Mangum |
| Correspondent | Kimberly Mangum Siemens Medical Solutions USA, Inc. 40 Liberty Blvd., Mail Code 65-1A Malvern, PA 19355 |
| Product Code | MUJ |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-08-24 |
| Decision Date | 2016-10-25 |
| Summary: | summary |