www.fdanews.com/articles/206627-casio-obtains-510k-clearance-for-its-dermocamera-and-scope-for-skin-monitoring
Casio Obtains 510(K) Clearance for its Dermocamera and Scope for Skin Monitoring
February 17, 2022
Casio America has received the FDA’s 510(k) clearance for its DZ-D100 Dermocamera and DZ-S50 scope for skin observation.
The DZ-D100 camera, which can be used to take both standard-sized and close-up images of an affected area, uses the company’s DZ Image Viewer software to manage the captured images.
The DZ-D100 and DZ-S50 have been classified by the FDA as Class I devices, meaning they pose low or moderate risk to patient health and safety.
The Dover, N.J.-based subsidiary of Japanese tech giant Casio Computer said that it plans to make the devices available in the U.S. by March.