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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 the device name listed in this FDA 510(k) record. The listed applicant is Varex Imaging Corporation. It received FDA 510(k) clearance on 2018-07-03 under 510(k) 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. The listed applicant is Varex Imaging Corporation. The 510(k) number is K181526.

When did XRpad2 4343 HWC-M Flat Panel Detector receive FDA 510(k) clearance?

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

Who is the listed applicant for XRpad2 4343 HWC-M Flat Panel Detector?

The FDA 510(k) record lists Varex Imaging Corporation as the applicant. This does not by itself establish the device manufacturer.

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.

Related Clinical Trials

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Other records listing Varex Imaging Corporation as applicant

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Related Devices (Code: MQB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K2538000909FCE, 0909FCE-HSRayence Co., Ltd.K260820VIVIX-S 4386W (FXRD-4386WA)Vieworks Co., Ltd.K252996Universal 1417PIKonica Minolta Healthcare Americas, Inc.K252911Lux HD 2530 detector (Lux HD 2530)Iray Imaging Technology (Haining) LimitedK250211Yushan X-Ray Flat Panel DetectorInnocare Optoelectronics Corp.K250665SKR 3000Konica Minolta, 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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