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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 K192894
Device Name Vita Flex CR System with LLI
Applicant
Carestream Health, Inc.
150 Verona Street
Rochester,  NY  14608
Applicant Contact Duane Gutowski
Correspondent
Carestream Health, Inc.
150 Verona Street
Rochester,  NY  14608
Correspondent Contact Duane Gutowski
Regulation Number892.1680
Classification Product Code
MQB  
Date Received10/11/2019
Decision Date 02/18/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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