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510(k) K243556

Lux HD 35 Detector (Lux HD 35); Lux HD 43 Detector (Lux HD 43) by Iray Imaging Technology (Haining) Limited — Product Code MQB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 18, 2025
Date Received
November 18, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Solid State X-Ray Imager (Flat Panel/Digital Imager)
Device Class
Class II
Regulation Number
892.1680
Review Panel
RA
Submission Type

Other clearances by Iray Imaging Technology (Haining) Limited

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Other clearances for product code MQB

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  • K243734 — Wireless/ Wired X-Ray Flat Panel Detectors (April 18, 2025)
  • K242770 — EXPD 114; EXPD 114G; EXPD 114P; EXPD 114PG (March 20, 2025)
  • K243443 — EXPD 4343N1; EXPD 4343N; EXPD 4343U1; EXPD 4343NU; EXPD 4343NP; EXPD 3643N1; EXP (March 19, 2025)
  • K244010 — ExamVue Apex (February 24, 2025)
  • K243171 — Yushan X-Ray Flat Panel Detector (December 19, 2024)
  • K241319 — SKR 3000 (November 21, 2024)
  • K241125 — VIVIX-S 1751S (November 15, 2024)