The following data is part of a premarket notification filed by Varian Medical Systems, Inc. with the FDA for Smart Segmentation - Knowledge Based Contouring.
| Device ID | K133227 |
| 510k Number | K133227 |
| Device Name: | SMART SEGMENTATION - KNOWLEDGE BASED CONTOURING |
| Classification | Accelerator, Linear, Medical |
| Applicant | VARIAN MEDICAL SYSTEMS, INC. 3100 HANSEN WAY Palo Alto, CA 94304 |
| Contact | Peter J Coronado |
| Correspondent | Peter J Coronado VARIAN MEDICAL SYSTEMS, INC. 3100 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 | 2013-10-21 |
| Decision Date | 2014-03-14 |
| Summary: | summary |