The following data is part of a premarket notification filed by Varian Medical Systems, Inc. with the FDA for Acuity With Conebeam Computed Tomography.
| Device ID | K033339 |
| 510k Number | K033339 |
| Device Name: | ACUITY WITH CONEBEAM COMPUTED TOMOGRAPHY |
| Classification | System, Simulation, Radiation Therapy |
| Applicant | VARIAN MEDICAL SYSTEMS, INC. 3100 HANSEN WAY Palo Alto, CA 94304 -1038 |
| Contact | Vy Tran |
| Correspondent | Vy Tran VARIAN MEDICAL SYSTEMS, INC. 3100 HANSEN WAY Palo Alto, CA 94304 -1038 |
| Product Code | KPQ |
| CFR Regulation Number | 892.5840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-10-17 |
| Decision Date | 2003-12-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00856545006010 | K033339 | 000 |