Dorex, Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 2
What Dorex, Inc. makes
Dorex, Inc. manufactures the DOREX SPECTRUM 9000MB THERMOGRAPHY SYSTEM, a medical imaging device used for thermal imaging and diagnostic thermography. The company also provides DCATS, a software or data management tool related to medical imaging or regulatory compliance.
The DOREX SPECTRUM 9000MB THERMOGRAPHY SYSTEM is classified as a Class III device under FDA regulations, while DCATS falls under Class I. Both are listed in the FDA’s 510(k) clearance registry. The company is based in the United States.
Catalogue
Dcats Ref K812799
510(k) 510(k)Dorex Spectrum 9000MB Thermography System Ref K023434
510(k) 510(k)
Frequently asked questions
How many devices does Dorex, Inc. have in the registry?
The registry currently lists 2 devices for Dorex, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Dorex, Inc.'s devices?
Among its 2 most recently registered devices, Dorex, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Dorex, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Dorex, Inc.'s devices are Class I and Class III. Each device page shows its own class and authorisation.
What are the newest devices from Dorex, Inc. in the registry?
The most recently registered devices listed for Dorex, Inc. include DCATS and DOREX SPECTRUM 9000MB THERMOGRAPHY SYSTEM.