Insightful Corporation
Country not established
- Devices
- 1
What Insightful Corporation makes
Insightful Corporation manufactures the IQUANTIFY software, Version 1.0, a medical device designed for quantitative analysis in imaging diagnostics, likely supporting measurements such as lesion characterization or volumetric assessments in radiology.
The IQUANTIFY software is classified as a Class II device under FDA regulations and is listed in the FDA’s 510(k) clearance registry. The company is based in the United States.
Catalogue
Iquantify, Version 1.0 Ref K011196
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Insightful Corporation have in the registry?
The registry currently lists 1 device for Insightful Corporation. Devices recorded under merged duplicate company entries are counted once.
Which registries list Insightful Corporation's devices?
Among its 1 most recently registered device, Insightful Corporation has devices listed in FDA 510(k) (1 device).
What risk classes do Insightful Corporation's devices fall under?
Among its 1 most recently registered device, the classes recorded for Insightful Corporation's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Insightful Corporation in the registry?
The most recently registered devices listed for Insightful Corporation include IQUANTIFY, VERSION 1.0.