FDA 510(k)

Flat Panel Detector

K-Number: K221714 · 2022-06-29

Decision Date2022-06-29

Product CodeMQB

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Flat Panel Detector is a medical device manufactured by Iray Technology Taicang , Ltd.. It received FDA 510(k) clearance on 2022-06-29 under approval number K221714. 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 Flat Panel Detector?

Flat Panel Detector is a medical device that received FDA 510(k) clearance on 2022-06-29. It is manufactured by Iray Technology Taicang , Ltd.. The 510(k) number is K221714.

When was Flat Panel Detector approved by the FDA?

Flat Panel Detector received FDA 510(k) clearance on 2022-06-29, under approval number K221714.

What company makes Flat Panel Detector?

Flat Panel Detector is manufactured by Iray Technology Taicang , Ltd..

What is the FDA product code for Flat Panel Detector?

The FDA product code for Flat Panel Detector is MQB.

Other Devices by Iray Technology Taicang , Ltd.

K182550Wireless Digital Flat Panel Detector K182551Wireless Digital Flat Panel Detector K192512Focus 35C Detector, Trimax 35C Detector K183713Wireless Digital Flat Detector K183422Wireless Digital Flat Panel Detector K201043Wireless Digital Flat Panel Detector (Model: Mars1717V-VSI, Mano4343W)

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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.