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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, Stationary
510(k) Number K250954
Device Name DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector, Lux HD 43 detector
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 Number892.1680
Classification Product Code
KPR  
Subsequent Product Code
MQB  
Date Received03/28/2025
Decision Date 01/20/2026
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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