Medical Device Manufacturer · US , Middleton , WI

Gammex, Inc. - FDA 510(k) Cleared Devices

3 submissions · 3 cleared · Since 1995

Recent clearances: CT Sim Laser System, PID-1 PRECISION INTELLIGENT DOSIMETER, COURIER II

View 3 510(k) Devices ↓

3

Total

3

Cleared

0

Denied

FDA 510(k) Regulatory Record - Gammex, Inc. Radiology ✕

3 devices

1-3 of 3

Cleared Sep 11, 2015

CT Sim Laser System

Radiology · 28d

Cleared Apr 22, 1996

PID-1 PRECISION INTELLIGENT DOSIMETER

Radiology · 203d

Cleared Oct 07, 1995

Radiology · 73d

Data Source

Sourced from the FDA 510(k) public files . 176,583 total devices indexed.

Last updated: Sep 12, 2026