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FDA 510(k)

Lux HD 35 Detector (Lux HD 35); Lux HD 43 Detector (Lux HD 43)

K-Number: K243556 · 2025-03-18

ApplicantIray Imaging Technology (Haining) Limited
Decision Date2025-03-18
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Lux HD 35 Detector (Lux HD 35); Lux HD 43 Detector (Lux HD 43) is a medical device manufactured by Iray Imaging Technology (Haining) Limited. It received FDA 510(k) clearance on 2025-03-18 under approval number K243556. 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 Lux HD 35 Detector (Lux HD 35); Lux HD 43 Detector (Lux HD 43)?

Lux HD 35 Detector (Lux HD 35); Lux HD 43 Detector (Lux HD 43) is a medical device that received FDA 510(k) clearance on 2025-03-18. It is manufactured by Iray Imaging Technology (Haining) Limited. The 510(k) number is K243556.

When was Lux HD 35 Detector (Lux HD 35); Lux HD 43 Detector (Lux HD 43) approved by the FDA?

Lux HD 35 Detector (Lux HD 35); Lux HD 43 Detector (Lux HD 43) received FDA 510(k) clearance on 2025-03-18, under approval number K243556.

What company makes Lux HD 35 Detector (Lux HD 35); Lux HD 43 Detector (Lux HD 43)?

Lux HD 35 Detector (Lux HD 35); Lux HD 43 Detector (Lux HD 43) is manufactured by Iray Imaging Technology (Haining) Limited.

What is the FDA product code for Lux HD 35 Detector (Lux HD 35); Lux HD 43 Detector (Lux HD 43)?

The FDA product code for Lux HD 35 Detector (Lux HD 35); Lux HD 43 Detector (Lux HD 43) is MQB.

Other Devices by Iray Imaging Technology (Haining) Limited

K230998Digital Wireless Intraoral X-Ray Sensor K230811Digital Intraoral X-Ray Sensor K252911Lux HD 2530 detector (Lux HD 2530)

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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