The following data is part of a premarket notification filed by Varian Medical Systems, X-ray Products-infimed with the FDA for Nexus Drtm Digital X-ray Imaging System (with Paxscan 4336wv4).
| Device ID | K161459 |
| 510k Number | K161459 |
| Device Name: | Nexus DRTM Digital X-ray Imaging System (with PaxScan 4336Wv4) |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | VARIAN MEDICAL SYSTEMS, X-RAY PRODUCTS-INFIMED 121 METROPOLITAN DRIVE Liverpool, NY 13088 |
| Contact | Catherine Mulcahy |
| Correspondent | Catherine Mulcahy VARIAN MEDICAL SYSTEMS, X-RAY PRODUCTS-INFIMED 121 METROPOLITAN DRIVE Liverpool, NY 13088 |
| Product Code | MQB |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-05-26 |
| Decision Date | 2016-09-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00854344007030 | K161459 | 000 |