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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 K213568
Device Name DRX-Rise 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  
Date Received11/09/2021
Decision Date 03/23/2022
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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