Canon Components, Inc.
Country not established FDA
- Devices
- 1
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA establishment
What Canon Components, Inc. makes
Canon Components, Inc. manufactures the CX-1, a digital retinal camera designed for ophthalmic imaging to capture high-resolution images of the retina. The device supports diagnostic evaluations of retinal conditions, including diseases like diabetic retinopathy and age-related macular degeneration.
The CX-1 is classified as a Class II medical device in the US and is listed under FDA 510(k) clearance. The company is based in the United States.
Catalogue
Digital Retinal Camera Cx-1 Ref K092565
510(k) 510(k)
FDA establishments
- Canon Components, Inc. KODAMA-GUN Saitama · JP FEI 1000582291
Frequently asked questions
How many devices does Canon Components, Inc. have in the registry?
The registry currently lists 1 device for Canon Components, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Canon Components, Inc.'s devices?
Among its 1 most recently registered device, Canon Components, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Canon Components, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Canon Components, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Canon Components, Inc. in the registry?
The most recently registered devices listed for Canon Components, Inc. include DIGITAL RETINAL CAMERA CX-1.
Which FDA establishments are linked to Canon Components, Inc.?
1 FDA establishment is linked to Canon Components, Inc. in the registry; they are listed on the company page.