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FDA 510(k)

XRpad2 4343 HWC-M Flat Panel Detector

K-Number: K181526 · 2018-07-03

ApplicantVarex Imaging Corporation
Decision Date2018-07-03
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

XRpad2 4343 HWC-M Flat Panel Detector is a medical device manufactured by Varex Imaging Corporation. It received FDA 510(k) clearance on 2018-07-03 under approval number K181526. The device is classified under product code MQB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the XRpad2 4343 HWC-M Flat Panel Detector?

XRpad2 4343 HWC-M Flat Panel Detector is a medical device that received FDA 510(k) clearance on 2018-07-03. It is manufactured by Varex Imaging Corporation. The 510(k) number is K181526.

When was XRpad2 4343 HWC-M Flat Panel Detector approved by the FDA?

XRpad2 4343 HWC-M Flat Panel Detector received FDA 510(k) clearance on 2018-07-03, under approval number K181526.

What company makes XRpad2 4343 HWC-M Flat Panel Detector?

XRpad2 4343 HWC-M Flat Panel Detector is manufactured by Varex Imaging Corporation.

What is the FDA product code for XRpad2 4343 HWC-M Flat Panel Detector?

The FDA product code for XRpad2 4343 HWC-M Flat Panel Detector is MQB.

Other Devices by Varex Imaging Corporation

K172951Nexus DR Digital X-ray Imaging System (with PaxScan 4343RC and PaxScan 4343Rv3) K171138Nexus DR Digital X-ray Imaging System K183212Nexus DR Digital X-ray Imaging System with stitching K193238Nexus DR Digital X-Ray Imaging System (with vSharp) K190146Nexus DR Digital X-ray Imaging System

Related Devices (Code: MQB)

K162555EVS 4343, EVS 4343GDRTECH Corporation K162344INNOLUX RICInnolux Corporation K161730Wireless Digital Flat Panel DetectorIray Technology (Shanghai) , Ltd. K162552EVS 3643, EVS 3643GDRTECH Corporation K163019CareView 750Cw/750C X-ray Flat Panel DetectorsCareray Digital Medical System Co., Ltd. K160143ClearVision ExamVue Flat Panel DetectorJpi Healthcare, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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