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FDA 510(k) Applications Submitted by Gabriel Issa
FDA 510(k) Number
Submission Date
Device Name
Applicant
K200726
03/20/2020
AcuityPDR
Radmedix LLC
K210919
03/29/2021
AcuityDRe
Radmedix LLC
K201058
04/21/2020
Accuvue+
Radmedix LLC
K231709
06/12/2023
AcuityDR 1013 G4, AcuityDR 1417 G4, AcuityDR 1717G4
Radmedix LLC
K193360
12/04/2019
Acuity SDR Standard, Acuity SDR Plus, Acuity FDR Standard
Radmedix LLC
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