Gammex, Inc.
United StatesFDA applicant, unverified
- Devices
- 3
What Gammex, Inc. makes
Gammex, Inc. manufactures the COURIER II, a medical transport device designed for patient mobility, and the PID-1 Precision Intelligent Dosimeter, a radiation measurement tool for monitoring exposure levels. The company also produces the CT Sim Laser System, used in computed tomography simulation for precise patient alignment and imaging planning.
The COURIER II is classified as Class I, while the PID-1 and CT Sim Laser System fall under Class II. These devices are listed in the FDA’s 510(k) registry, reflecting their regulatory clearance pathway. Gammex, Inc. is headquartered in the United States.
Catalogue
Courier Ii Ref K953514
Regimes: 510(k) Registry: 510(k)Pid-1 Precision Intelligent Dosimeter Ref K954564
Regimes: 510(k) Registry: 510(k)CT Sim Laser System Ref K152303
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Gammex, Inc. have in the registry?
The registry currently lists 3 devices for Gammex, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Gammex, Inc.'s devices?
Among its 3 most recently registered devices, Gammex, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Gammex, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Gammex, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Gammex, Inc. in the registry?
The most recently registered devices listed for Gammex, Inc. include COURIER II, PID-1 PRECISION INTELLIGENT DOSIMETER and CT Sim Laser System.