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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 K202441
Device Name Eclipse II with Smart Noise Cancellation
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 gina maiolo
Regulation Number892.1680
Classification Product Code
MQB  
Date Received08/26/2020
Decision Date 04/02/2021
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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