The following data is part of a premarket notification filed by Varian Medical Systems, Inc with the FDA for Respiratory Gating For Scanners.
| Device ID | K151533 |
| 510k Number | K151533 |
| Device Name: | Respiratory Gating For Scanners |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-06-08 |
| Decision Date | 2015-08-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00856100006028 | K151533 | 000 |
| 00856100006158 | K151533 | 000 |