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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 K180809
Device Name Eclipse II
Applicant
Carestream Health, Inc
150 Verona Street
Rochester,  NY  14608
Applicant Contact Diane Koetter
Correspondent
Carestream Health, Inc
150 Verona Street
Rochester,  NY  14608
Correspondent Contact Diane Koetter
Regulation Number892.1680
Classification Product Code
MQB  
Date Received03/28/2018
Decision Date 06/21/2018
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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