The following data is part of a premarket notification filed by Varian Medical Systems, Inc. with the FDA for Acuity Radiation Therapy Simulator.
Device ID | K023052 |
510k Number | K023052 |
Device Name: | ACUITY RADIATION THERAPY SIMULATOR |
Classification | System, Simulation, Radiation Therapy |
Applicant | VARIAN MEDICAL SYSTEMS, INC. 3100 HANSEN WAY Palo Alto, CA 94304 |
Contact | Linda S Nash |
Correspondent | Linda S Nash VARIAN MEDICAL SYSTEMS, INC. 3100 HANSEN WAY Palo Alto, CA 94304 |
Product Code | KPQ |
CFR Regulation Number | 892.5840 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-09-13 |
Decision Date | 2002-10-11 |
Summary: | summary |