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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 the device name listed in this FDA 510(k) record. The listed applicant is Iray Imaging Technology (Haining) Limited. It received FDA 510(k) clearance on 2025-03-18 under 510(k) 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. The listed applicant is Iray Imaging Technology (Haining) Limited. The 510(k) number is K243556.

When did Lux HD 35 Detector (Lux HD 35); Lux HD 43 Detector (Lux HD 43) receive FDA 510(k) clearance?

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

Who is the listed applicant for Lux HD 35 Detector (Lux HD 35); Lux HD 43 Detector (Lux HD 43)?

The FDA 510(k) record lists Iray Imaging Technology (Haining) Limited as the applicant. This does not by itself establish the device manufacturer.

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 records listing Iray Imaging Technology (Haining) Limited as applicant

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.

K252911Lux HD 2530 detector (Lux HD 2530)K230998Digital Wireless Intraoral X-Ray SensorK230811Digital Intraoral X-Ray Sensor

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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