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FDA 510(k)

Wireless Digital Flat Detector

K-Number: K183713 · 2019-01-09

ApplicantIray Technology Taicang , Ltd.
Decision Date2019-01-09
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Wireless Digital Flat Detector is a medical device manufactured by Iray Technology Taicang , Ltd.. It received FDA 510(k) clearance on 2019-01-09 under approval number K183713. 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 Wireless Digital Flat Detector?

Wireless Digital Flat Detector is a medical device that received FDA 510(k) clearance on 2019-01-09. It is manufactured by Iray Technology Taicang , Ltd.. The 510(k) number is K183713.

When was Wireless Digital Flat Detector approved by the FDA?

Wireless Digital Flat Detector received FDA 510(k) clearance on 2019-01-09, under approval number K183713.

What company makes Wireless Digital Flat Detector?

Wireless Digital Flat Detector is manufactured by Iray Technology Taicang , Ltd..

What is the FDA product code for Wireless Digital Flat Detector?

The FDA product code for Wireless Digital Flat 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 K183422Wireless Digital Flat Panel Detector K201043Wireless Digital Flat Panel Detector (Model: Mars1717V-VSI, Mano4343W) K201004Wireless Digital Flat Panel Detector Model Name Mars1417V-TSI, Wireless Digital Flat Panel Detector Model Name Mano4336W

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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.

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