Pointdx, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Pointdx, Inc. makes
Pointdx, Inc. manufactures diagnostic software tools, including the REX platform in versions 1.0 and 3.0, designed for analyzing and interpreting medical imaging data, such as radiographic images.
The company’s products are regulated as Class II devices under FDA 510(k) clearance requirements and are listed in the FDA’s 510(k) database. The company is headquartered in the United States.
Catalogue
Rex, Version 1.0 Ref K021099
Regimes: 510(k) Registry: 510(k)Rex, Version 3.0 Ref K030457
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Pointdx, Inc. have in the registry?
The registry currently lists 2 devices for Pointdx, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Pointdx, Inc.'s devices?
Among its 2 most recently registered devices, Pointdx, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Pointdx, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Pointdx, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Pointdx, Inc. in the registry?
The most recently registered devices listed for Pointdx, Inc. include REX, VERSION 1.0 and REX, VERSION 3.0.