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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Solid State X-Ray Imager (Flat Panel/Digital Imager)
510(k) Number K243556
Device Name Lux HD 35 Detector (Lux HD 35); Lux HD 43 Detector (Lux HD 43)
Applicant
Iray Imaging Technology (Haining) Limited
# 2, Caohejing Rd.
Haining,  CN 314499
Applicant Contact Junjie Qian
Correspondent
Iray Imaging Technology (Haining) Limited
# 2, Caohejing Rd.
Haining,  CN 314499
Correspondent Contact Junjie Qian
Regulation Number892.1680
Classification Product Code
MQB  
Date Received11/18/2024
Decision Date 03/18/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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