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FDA 510(k)

Yushan X-Ray Flat Panel Detector with DROC

K-Number: K220510 · 2022-04-14

ApplicantInnocare Optoelectronics Corp.
Decision Date2022-04-14
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Yushan X-Ray Flat Panel Detector with DROC is a medical device manufactured by Innocare Optoelectronics Corp.. It received FDA 510(k) clearance on 2022-04-14 under approval number K220510. 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 Yushan X-Ray Flat Panel Detector with DROC?

Yushan X-Ray Flat Panel Detector with DROC is a medical device that received FDA 510(k) clearance on 2022-04-14. It is manufactured by Innocare Optoelectronics Corp.. The 510(k) number is K220510.

When was Yushan X-Ray Flat Panel Detector with DROC approved by the FDA?

Yushan X-Ray Flat Panel Detector with DROC received FDA 510(k) clearance on 2022-04-14, under approval number K220510.

What company makes Yushan X-Ray Flat Panel Detector with DROC?

Yushan X-Ray Flat Panel Detector with DROC is manufactured by Innocare Optoelectronics Corp..

What is the FDA product code for Yushan X-Ray Flat Panel Detector with DROC?

The FDA product code for Yushan X-Ray Flat Panel Detector with DROC is MQB.

Other Devices by Innocare Optoelectronics Corp.

K191939Yushan X-Ray Flat Panel Detector K201528Yushan X-Ray Flat Panel Detector with DROC K210988Yushan X-Ray Flat Panel Detector with DROC K243171Yushan X-Ray Flat Panel Detector K250211Yushan X-Ray Flat Panel Detector

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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