Lux HD 35 Detector (Lux HD 35); Lux HD 43 Detector (Lux HD 43)— 510(k) K243556

Name: FDA 510(k) clearance K243556
Creator: U.S. Food and Drug Administration
Published: 2025-03-18

Substantially Equivalent

Iray Imaging Technology (Haining) Limited

FDA 510(k) clearance K243556 for Lux HD 35 Detector (Lux HD 35); Lux HD 43 Detector (Lux HD 43), Substantially Equivalent on 2025-03-18. 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: 2024-11-18
Decision date: 2025-03-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Haining, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code MQB

view all

K253800 — 0909FCE, 0909FCE-HS2026-07-31
K260820 — VIVIX-S 4386W (FXRD-4386WA)2026-06-18
K252996 — Universal 1417PI2026-06-12
K252911 — Lux HD 2530 detector (Lux HD 2530)2025-10-09
K250211 — Yushan X-Ray Flat Panel Detector2025-07-22

More clearances from Iray Imaging Technology (Haining) Limited

view all

K230998 — Digital Wireless Intraoral X-Ray Sensor2023-10-20
K230811 — Digital Intraoral X-Ray Sensor2023-04-21

Data sourced from openFDA. This site is unofficial and independent of the FDA.