The following data is part of a premarket notification filed by Varian Medical Systems, Inc. with the FDA for Varian Head Frame.
| Device ID | K180586 |
| 510k Number | K180586 |
| Device Name: | Varian Head Frame |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-03-05 |
| Decision Date | 2018-04-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00899475002394 | K180586 | 000 |
| 10899475002490 | K180586 | 000 |
| 00858086006252 | K180586 | 000 |
| 10858086006280 | K180586 | 000 |
| 00858086006306 | K180586 | 000 |
| 00858086006313 | K180586 | 000 |
| 20858086006263 | K180586 | 000 |
| 30858086006277 | K180586 | 000 |
| 00858086006290 | K180586 | 000 |
| 00858086006634 | K180586 | 000 |