Skanray Technologies
IndiaFDA applicant, unverified
Skanray Technologies is a medical device manufacturer, with 24 devices listed in FDA GUDID, EUDAMED and FDA 510(k) (FDA Class II) as of 15 Nov 2026.
- Devices
- 24
Registry facts
- Registries
- FDA GUDID 23
- EUDAMED 4
- FDA 510(k) 1
- Device classes
- FDA Class II 24
What Skanray Technologies makes
Skanray Technologies manufactures digital intraoral dental X-ray systems, including both stationary and mobile units like the Rayos DC and Intraskan DC Plus, as well as stationary basic diagnostic X-ray systems such as the PodSKAN HF. The company also produces general-purpose bedside monitors (e.g., Star 60, Star 65, Star 90) and centralized patient monitoring solutions. Automatic-inflation electronic sphygmomanometers, such as the SPOTSKAN, are part of their portfolio.
The company’s devices are classified under Class II in the US and are authorised through FDA pathways, including 510(k) clearances and the FDA’s Unique Device Identification (UDI) system. These products are listed under regulatory registries for medical imaging and monitoring equipment.
Catalogue
Search and filter all 24 devicesFrequently asked questions
How many devices does Skanray Technologies have in the registry?
The registry currently lists 24 devices for Skanray Technologies. Devices recorded under merged duplicate company entries are counted once.
Which registries list Skanray Technologies's devices?
Among its 24 most recently registered devices, Skanray Technologies has devices listed in EUDAMED (4 devices), FDA 510(k) (1 device) and FDA GUDID (23 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Skanray Technologies's devices fall under?
Among its 24 most recently registered devices, the classes recorded for Skanray Technologies's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Skanray Technologies in the registry?
The most recently registered devices listed for Skanray Technologies include Rayos DC 303-000134-80, Imagescan HD 303-001204-0, PodSKAN HF Diagnostic X-ray System 303-002665-0 and Imagescan HD 303-001202-0.