The following data is part of a premarket notification filed by Varian Medical Systems, Inc. with the FDA for Aria Radiation Therapy Management.
Device ID | K133572 |
510k Number | K133572 |
Device Name: | ARIA RADIATION THERAPY MANAGEMENT |
Classification | Accelerator, Linear, Medical |
Applicant | VARIAN MEDICAL SYSTEMS, INC. 3120 HANSEN WAY C-260 Palo Alto, CA 94304 |
Contact | Peter J Coronado |
Correspondent | Peter J Coronado VARIAN MEDICAL SYSTEMS, INC. 3120 HANSEN WAY C-260 Palo Alto, CA 94304 |
Product Code | IYE |
CFR Regulation Number | 892.5050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-11-20 |
Decision Date | 2014-04-04 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00856100006004 | K133572 | 000 |