510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K243556Substantially Equivalent

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

iRay Imaging Technology (Haining) Limited, Haining, CN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K243556 is the FDA 510(k) clearance record for Lux HD 35 Detector (Lux HD 35); Lux HD 43 Detector (Lux HD 43), a class II device, cleared for Iray Imaging Technology (Haining) Limited on under FDA product code MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager)). FDA records list 4 510(k) clearances for Iray Imaging Technology (Haining) Limited, from to . As of , FDA records show no recalls naming K243556.

Clearance record

Decision date
Received
(120 days to decision)
Product code
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Regulation
21 CFR 892.1680
Device class
Class II
Review panel
Radiology
Applicant
Iray Imaging Technology (Haining) Limited # 2, Caohejing Rd., Haining, CN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MQB

Trailing 12 months
3 clearances under product code MQB in the twelve months to October 2026, June 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code MQB, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20262
July 20261
August 20260
September 20260
October 20260