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.
Device ID | K190146 |
510k Number | K190146 |
Device Name: | Nexus DR Digital X-ray Imaging System |
Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
Applicant | Varex Imaging Corporation 121 Metropolitan Drive Liverpool, NY 13088 |
Contact | Michael G. Van Ryn |
Correspondent | Michael G. 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 | 2019-01-29 |
Decision Date | 2019-03-08 |