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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Mobile
510(k) Number K253185
Device Name Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray System
Applicant
Carestream Health
150 Verona St.
Rochester,  NY  14608
Applicant Contact Gina Maiolo
Correspondent
Carestream Health
150 Verona St.
Rochester,  NY  14608
Correspondent Contact Gina Maiolo
Regulation Number892.1720
Classification Product Code
IZL  
Subsequent Product Code
MQB  
Date Received09/26/2025
Decision Date 03/11/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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