Cleared Special

Lux HD 2530 detector (Lux HD 2530)

K252911 · Iray Imaging Technology (Haining) Limited · Radiology
Oct 2025
Decision
27d
Days
Class 2
Risk

About This 510(k) Submission

K252911 is an FDA 510(k) clearance for the Lux HD 2530 detector (Lux HD 2530), a Solid State X-ray Imager (flat Panel/digital Imager) (Class II — Special Controls, product code MQB), submitted by Iray Imaging Technology (Haining) Limited (Haining, CN). The FDA issued a Cleared decision on October 9, 2025, 27 days after receiving the submission on September 12, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1680.

Submission Details

510(k) Number K252911 FDA.gov
FDA Decision Cleared SESE
Date Received September 12, 2025
Decision Date October 09, 2025
Days to Decision 27 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code MQB — Solid State X-ray Imager (flat Panel/digital Imager)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1680

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