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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 K210919
Device Name AcuityDRe
Radmedix LLC
2510 Lance Dr.
dayton,  OH  45409
Applicant Contact gabriel issa
Kamm & Associates
8870 Ravello Ct
naples,  FL  45409
Correspondent Contact daniel kamm
Regulation Number892.1680
Classification Product Code
Subsequent Product Code
Date Received03/29/2021
Decision Date 04/30/2021
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No