Cleared Traditional

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

K243556 · Iray Imaging Technology (Haining) Limited · Radiology
Mar 2025
Decision
120d
Days
Class 2
Risk

About This 510(k) Submission

K243556 is an FDA 510(k) clearance for the Lux HD 35 Detector (Lux HD 35); Lux HD 43 Detector (Lux HD 43), 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 March 18, 2025, 120 days after receiving the submission on November 18, 2024. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1680.

Submission Details

510(k) Number K243556 FDA.gov
FDA Decision Cleared SESE
Date Received November 18, 2024
Decision Date March 18, 2025
Days to Decision 120 days
Submission Type Traditional
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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