Medimaging Integrated Solutions, Inc. (Miis)
ChinaFDA applicant, unverified
- Devices
- 1
What Medimaging Integrated Solutions, Inc. (Miis) makes
Medimaging Integrated Solutions, Inc. manufactures a digital eye-fundus camera, designed for retinal imaging to capture detailed images of the retina’s interior surface. This device supports clinical assessments of retinal conditions, diabetic retinopathy, and age-related macular degeneration.
The company’s digital eye-fundus camera is classified as a Class II medical device in the U.S. and is listed under FDA’s 510(k) pathway. The device is regulated under U.S. jurisdiction and is not currently authorised in other markets.
Catalogue
Digital Eye-Fundus Camera Ref K120982
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Medimaging Integrated Solutions, Inc. (Miis) have in the registry?
The registry currently lists 1 device for Medimaging Integrated Solutions, Inc. (Miis). Devices recorded under merged duplicate company entries are counted once.
Which registries list Medimaging Integrated Solutions, Inc. (Miis)'s devices?
Among its 1 most recently registered device, Medimaging Integrated Solutions, Inc. (Miis) has devices listed in FDA 510(k) (1 device).
What risk classes do Medimaging Integrated Solutions, Inc. (Miis)'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Medimaging Integrated Solutions, Inc. (Miis)'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Medimaging Integrated Solutions, Inc. (Miis) in the registry?
The most recently registered devices listed for Medimaging Integrated Solutions, Inc. (Miis) include DIGITAL EYE-FUNDUS CAMERA.