XRpad2 4343 HWC-M Flat Panel Detector

Solid State X-ray Imager (flat Panel/digital Imager)

Varex Imaging Corporation

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.

Pre-market Notification Details

Device IDK181526
510k NumberK181526
Device Name:XRpad2 4343 HWC-M Flat Panel Detector
ClassificationSolid State X-ray Imager (flat Panel/digital Imager)
Applicant Varex Imaging Corporation 2175 Mission College Blvd. Santa Clara,  CA  95054
ContactPaul Sawicki
CorrespondentPaul Sawicki
Varex Imaging Corporation 2175 Mission College Blvd. Santa Clara,  CA  95054
Product CodeMQB  
CFR Regulation Number892.1680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-06-11
Decision Date2018-07-03
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00810751030009 K181526 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.