Medical Device Manufacturer · US , Dayton , OH

Radmedix, LLC - FDA 510(k) Cleared Devices

6 submissions · 6 cleared · Since 2020

Recent clearances: AcuityUDR, AcuityDR 1013 G4, AcuityDR 1417 G4, AcuityDR 1717G4, AcuityDRe

6

Total

6

Cleared

0

Denied

FDA 510(k) Regulatory Record - Radmedix, LLC Radiology ✕

6 devices

1-6 of 6

Cleared Oct 25, 2023

Radiology · 112d

Cleared Jul 12, 2023

AcuityDR 1013 G4, AcuityDR 1417 G4, AcuityDR 1717G4

Radiology · 30d

Cleared Apr 30, 2021

Radiology · 32d

Cleared May 06, 2020

Radiology · 15d

Cleared Apr 13, 2020

Radiology · 24d

Cleared Jan 02, 2020

Acuity SDR Standard, Acuity SDR Plus, Acuity FDR Standard

Radiology · 29d

Data Source

Sourced from the FDA 510(k) public files . 175,730 total devices indexed.

Last updated: May 14, 2026