Image Diagnost International GmbH
Country not established
- Devices
- 2
What Image Diagnost International GmbH makes
Image Diagnost International GmbH manufactures mammography workstations designed for breast imaging. These devices are intended for use in diagnostic and screening procedures to produce detailed images of breast tissue, aiding in the detection and evaluation of abnormalities such as tumors or calcifications.
The company’s portfolio is regulated under Class II medical devices in the United States, with products authorised through the FDA’s 510(k) clearance process. These devices are listed in the FDA’s 510(k) registry, ensuring compliance with U.S. medical device regulations.
Catalogue
Mammoworkstation Ref K123575
Regimes: 510(k) Registry: 510(k)Mammo Workstation Ref K081630
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Image Diagnost International GmbH have in the registry?
The registry currently lists 2 devices for Image Diagnost International GmbH. Devices recorded under merged duplicate company entries are counted once.
Which registries list Image Diagnost International GmbH's devices?
Among its 2 most recently registered devices, Image Diagnost International GmbH has devices listed in FDA 510(k) (2 devices).
What risk classes do Image Diagnost International GmbH's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Image Diagnost International GmbH's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Image Diagnost International GmbH in the registry?
The most recently registered devices listed for Image Diagnost International GmbH include MAMMOWORKSTATION and MAMMO WORKSTATION.