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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 K190691
Device Name Pixx2430 Digital Diagnostic X-Ray Receptor Panel
Applicant
Pixxgen Corporation
5f, Smart Bay, 123, Beolmal-Ro, Dongan-Gu
Anyang-Si,,  KR 14056
Applicant Contact John Ross
Correspondent
Kamm & Associates
8870 Ravello Ct.
Naples,  FL  34114
Correspondent Contact Daniel Kamm
Regulation Number892.1680
Classification Product Code
MQB  
Date Received03/18/2019
Decision Date 04/04/2019
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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