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 | K133247 |
| 510k Number | K133247 |
| Device Name: | ECLIPSE TREATMENT PLANNING SYSTEM |
| Classification | System, Planning, Radiation Therapy Treatment |
| Applicant | VARIAN MEDICAL SYSTEMS, INC. 911 HANSEN WAY Palo Alto, CA 94304 |
| Contact | Peter J Coronado |
| Correspondent | Peter J Coronado VARIAN MEDICAL SYSTEMS, INC. 911 HANSEN WAY Palo Alto, CA 94304 |
| Product Code | MUJ |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-10-22 |
| Decision Date | 2014-02-07 |
| Summary: | summary |