Applicare Medical Imaging, B.V.
Country not established
- Devices
- 2
What Applicare Medical Imaging, B.V. makes
Applicare Medical Imaging, B.V. develops RADWORKS Medical Imaging Software, a diagnostic tool for processing and analyzing medical images, including X-rays, CT scans, and MRIs. The software supports workflow automation, image enhancement, and basic diagnostic functions. An optional Quality Control Module integrates automated checks for image quality and consistency in clinical settings.
The company’s products are classified under FDA 510(k) pathways, with some devices falling under Class I and others under Class II regulatory categories. The portfolio is registered with the U.S. Food and Drug Administration (FDA) under the 510(k) premarket notification process. The company is based in the United States.
Catalogue
Radworks Medical Imaging Software Ref K962699
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Applicare Medical Imaging, B.V. have in the registry?
The registry currently lists 2 devices for Applicare Medical Imaging, B.V.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Applicare Medical Imaging, B.V.'s devices?
Among its 2 most recently registered devices, Applicare Medical Imaging, B.V. has devices listed in FDA 510(k) (2 devices).
What risk classes do Applicare Medical Imaging, B.V.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Applicare Medical Imaging, B.V.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Applicare Medical Imaging, B.V. in the registry?
The most recently registered devices listed for Applicare Medical Imaging, B.V. include RADWORKS MEDICAL IMAGING SOFTWARE and RADWORKS MEDICAL IMAGING SOFTWARE WITH QUALITY CONTROL MODULE.