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 | K073020 |
510k Number | K073020 |
Device Name: | ECLIPSE TREATMENT PLANNING SYSTEM |
Classification | System, Planning, Radiation Therapy Treatment |
Applicant | VARIAN MEDICAL SYSTEMS, INC. 3100 HANSEN WAY, E-110 Palo Alto, CA 94304 -1129 |
Contact | Vy Tran |
Correspondent | Vy Tran VARIAN MEDICAL SYSTEMS, INC. 3100 HANSEN WAY, E-110 Palo Alto, CA 94304 -1129 |
Product Code | MUJ |
CFR Regulation Number | 892.5050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-10-26 |
Decision Date | 2007-12-19 |
Summary: | summary |