The following data is part of a premarket notification filed by Varex Imaging Corporation with the FDA for Xrpad2 4343 Hwc-m Flat Panel Detector.
| Device ID | K181526 |
| 510k Number | K181526 |
| Device Name: | XRpad2 4343 HWC-M Flat Panel Detector |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | Varex Imaging Corporation 2175 Mission College Blvd. Santa Clara, CA 95054 |
| Contact | Paul Sawicki |
| Correspondent | Paul Sawicki Varex Imaging Corporation 2175 Mission College Blvd. Santa Clara, CA 95054 |
| Product Code | MQB |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-06-11 |
| Decision Date | 2018-07-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810751030009 | K181526 | 000 |