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 Stitching.
| Device ID | K183212 |
| 510k Number | K183212 |
| Device Name: | Nexus DR Digital X-ray Imaging System With Stitching |
| 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 | 2018-11-19 |
| Decision Date | 2018-12-07 |
| Summary: | summary |