Carl Zeiss Jena GmbH
Country not established
- Devices
- 1
What Carl Zeiss Jena GmbH makes
Carl Zeiss Jena GmbH manufactures the FF450 PLUS Fundus Camera integrated with the VisuPac digital image archiving system, designed for retinal imaging and documentation in clinical settings. This system captures high-resolution images of the retina and stores them electronically for diagnostic and monitoring purposes.
The FF450 PLUS VisuPac system is classified as a Class II medical device under FDA regulations and is listed via the 510(k) pathway. The company is based in the United States.
Catalogue
FF450 Plus Fundus Camera And Visupac Digital Image Archiving System, Or FF450 Plus Visupac System Ref K011877
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Carl Zeiss Jena GmbH have in the registry?
The registry currently lists 1 device for Carl Zeiss Jena GmbH. Devices recorded under merged duplicate company entries are counted once.
Which registries list Carl Zeiss Jena GmbH's devices?
Among its 1 most recently registered device, Carl Zeiss Jena GmbH has devices listed in FDA 510(k) (1 device).
What risk classes do Carl Zeiss Jena GmbH's devices fall under?
Among its 1 most recently registered device, the classes recorded for Carl Zeiss Jena GmbH's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Carl Zeiss Jena GmbH in the registry?
The most recently registered devices listed for Carl Zeiss Jena GmbH include FF450 PLUS FUNDUS CAMERA AND VISUPAC DIGITAL IMAGE ARCHIVING SYSTEM, OR FF450 PLUS VISUPAC SYSTEM.