The following data is part of a premarket notification filed by Varian Medical Systems, Inc. with the FDA for Eclipse Treatment Planning System.
| Device ID | K181145 |
| 510k Number | K181145 |
| Device Name: | Eclipse Treatment Planning System |
| Classification | System, Planning, Radiation Therapy Treatment |
| Applicant | Varian Medical Systems, Inc. 911 Hensen Way Palo Alto, CA 94304 |
| Contact | Peter J. Coronado |
| Correspondent | Peter J. Coronado Varian Medical Systems, Inc. 911 Hensen Way Palo Alto, CA 94304 |
| Product Code | MUJ |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-05-01 |
| Decision Date | 2018-05-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00855141006066 | K181145 | 000 |
| 00855141006035 | K181145 | 000 |