Mlhealth 360
CanadaFDA applicant, unverified
- Devices
- 1
What Mlhealth 360 makes
Mlhealth 360 develops the Scaida BrainCT-ICH (v1.0), a software-based tool designed for analyzing computed tomography (CT) scans to detect intracerebral hemorrhage (ICH) in brain imaging.
The company’s portfolio is regulated under FDA Class II devices and includes products listed via the 510(k) clearance pathway. The company is based in the United States.
Catalogue
Scaida BrainCT-ICH (v1.0) Ref K250694
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Mlhealth 360 have in the registry?
The registry currently lists 1 device for Mlhealth 360. Devices recorded under merged duplicate company entries are counted once.
Which registries list Mlhealth 360's devices?
Among its 1 most recently registered device, Mlhealth 360 has devices listed in FDA 510(k) (1 device).
What risk classes do Mlhealth 360's devices fall under?
Among its 1 most recently registered device, the classes recorded for Mlhealth 360's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Mlhealth 360 in the registry?
The most recently registered devices listed for Mlhealth 360 include Scaida BrainCT-ICH (v1.0).