The following data is part of a premarket notification filed by Varex Imaging Corporation with the FDA for Nexus Dr Digital X-ray Imaging System (with Paxscan 4343rc And Paxscan 4343rv3).
| Device ID | K172951 |
| 510k Number | K172951 |
| Device Name: | Nexus DR Digital X-ray Imaging System (with PaxScan 4343RC And PaxScan 4343Rv3) |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | Varex Imaging Corporation 121 Metropolitan Drive Liverpool, NY 13088 |
| Contact | Catherine Mulcahy |
| Correspondent | Catherine Mulcahy Varex Imaging Corporation 121 Metropolitan Drive Liverpool, NY 13088 |
| Product Code | MQB |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-26 |
| Decision Date | 2017-10-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00854344007184 | K172951 | 000 |