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 Vsharp).
| Device ID | K193238 |
| 510k Number | K193238 |
| Device Name: | Nexus DR Digital X-Ray Imaging System (with VSharp) |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | Varex Imaging Corporation 121 Metropolitan Drive Liverpool, NY 13088 |
| Contact | Michael Van Ryn |
| Correspondent | Michael Van Ryn 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 | 2019-11-25 |
| Decision Date | 2019-12-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00854344007726 | K193238 | 000 |
| 00854344007696 | K193238 | 000 |
| 00854344007672 | K193238 | 000 |
| 00854344007733 | K193238 | 000 |
| 00854344007740 | K193238 | 000 |
| 00854344007757 | K193238 | 000 |