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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Stationary
510(k) Number K193360
Device Name Acuity SDR Standard, Acuity SDR Plus, Acuity FDR Standard
Applicant
Radmedix, LLC
2510 Lance Dr.
Dayton,  OH  45409
Applicant Contact Gabriel Issa
Correspondent
Kamm & Associates
8870 Ravello Ct.
Naples,  FL  34114
Correspondent Contact Daniel Kamm
Regulation Number892.1680
Classification Product Code
KPR  
Subsequent Product Code
MQB  
Date Received12/04/2019
Decision Date 01/02/2020
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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