The following data is part of a premarket notification filed by Varian Medical Systems, Inc. with the FDA for Respiratory Gating For Scanners V2.0.
| Device ID | K213927 |
| 510k Number | K213927 |
| Device Name: | Respiratory Gating For Scanners V2.0 |
| Classification | System, X-ray, Tomography, Computed |
| 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 | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-12-16 |
| Decision Date | 2022-01-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00856100006196 | K213927 | 000 |