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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 K203159
Device Name Lux 35 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
MQB  
Date Received10/23/2020
Decision Date 12/02/2020
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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