Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Lux HD 2530 detector (Lux HD 2530)

K-Number: K252911 · 2025-10-09

Decision Date2025-10-09
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Lux HD 2530 detector (Lux HD 2530) is a medical device manufactured by Iray Imaging Technology (Haining) Limited. It received FDA 510(k) clearance on 2025-10-09 under approval number K252911. 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 2530 detector (Lux HD 2530)?

Lux HD 2530 detector (Lux HD 2530) is a medical device that received FDA 510(k) clearance on 2025-10-09. It is manufactured by Iray Imaging Technology (Haining) Limited. The 510(k) number is K252911.

When was Lux HD 2530 detector (Lux HD 2530) approved by the FDA?

Lux HD 2530 detector (Lux HD 2530) received FDA 510(k) clearance on 2025-10-09, under approval number K252911.

What company makes Lux HD 2530 detector (Lux HD 2530)?

Lux HD 2530 detector (Lux HD 2530) is manufactured by Iray Imaging Technology (Haining) Limited.

What is the FDA product code for Lux HD 2530 detector (Lux HD 2530)?

The FDA product code for Lux HD 2530 detector (Lux HD 2530) is MQB.

Other Devices by Iray Imaging Technology (Haining) Limited

Related Devices (Code: MQB)

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.