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 |