The following data is part of a premarket notification filed by Varian Medical Systems, Oncology Systems with the FDA for Barcode Conical Collimator Verification (bccv).
| Device ID | K103394 |
| 510k Number | K103394 |
| Device Name: | BARCODE CONICAL COLLIMATOR VERIFICATION (BCCV) |
| Classification | Accelerator, Linear, Medical |
| Applicant | VARIAN MEDICAL SYSTEMS, ONCOLOGY SYSTEMS 911 HANSEN WAY Palo Alto, CA 94304 |
| Contact | Vy Tran |
| Correspondent | Vy Tran VARIAN MEDICAL SYSTEMS, ONCOLOGY SYSTEMS 911 HANSEN WAY 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 | 2010-11-19 |
| Decision Date | 2011-01-12 |
| Summary: | summary |