The following data is part of a premarket notification filed by Varian Medical Systems, Inc. with the FDA for Portalvision Advanced Imaging.
| Device ID | K091209 |
| 510k Number | K091209 |
| Device Name: | PORTALVISION ADVANCED IMAGING |
| Classification | Accelerator, Linear, Medical |
| Applicant | VARIAN MEDICAL SYSTEMS, INC. 3100 HANSEN WAY M/S E-110 Palo Alto, CA 94304 |
| Contact | Vy Tran |
| Correspondent | Vy Tran VARIAN MEDICAL SYSTEMS, INC. 3100 HANSEN WAY M/S E-110 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 | 2009-04-24 |
| Decision Date | 2009-06-23 |
| Summary: | summary |