Lux HD 2530 detector (Lux HD 2530)— 510(k) K252911

Name: FDA 510(k) clearance K252911
Creator: U.S. Food and Drug Administration
Published: 2025-10-09

Substantially Equivalent

Iray Imaging Technology (Haining) Limited

FDA 510(k) clearance K252911 for Lux HD 2530 detector (Lux HD 2530), Substantially Equivalent on 2025-10-09. Applicant: Iray Imaging Technology (Haining) Limited. Device class: 2.

Clearance details

Applicant: Iray Imaging Technology (Haining) Limited
Product code: Code MQB
Device class: Class 2
Regulation: 21 CFR 892.1680
Advisory panel: Radiology
Date received: 2025-09-12
Decision date: 2025-10-09
Decision: Substantially Equivalent
Clearance type: Special
Location: Haining, CN

Download summary PDF View on FDA.gov ↗

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