Andromeda Medizinische Systeme GmbH
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- Devices
- 1
What Andromeda Medizinische Systeme GmbH makes
Andromeda Medizinische Systeme GmbH manufactures the ELLIPSE 4, a medical device designed for intraoperative imaging and navigation, particularly in orthopedic and spinal surgeries. This system integrates imaging and surgical planning to support real-time visualization and guidance during procedures, enhancing precision and reducing operative risks.
The ELLIPSE 4 is classified as a Class II device under FDA regulations and has undergone 510(k) clearance. The company is based in the United States, with its product listed in the FDA’s 510(k) registry.
Catalogue
Ellipse 4 Ref K964522
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Andromeda Medizinische Systeme GmbH have in the registry?
The registry currently lists 1 device for Andromeda Medizinische Systeme GmbH. Devices recorded under merged duplicate company entries are counted once.
Which registries list Andromeda Medizinische Systeme GmbH's devices?
Among its 1 most recently registered device, Andromeda Medizinische Systeme GmbH has devices listed in FDA 510(k) (1 device).
What risk classes do Andromeda Medizinische Systeme GmbH's devices fall under?
Among its 1 most recently registered device, the classes recorded for Andromeda Medizinische Systeme GmbH's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Andromeda Medizinische Systeme GmbH in the registry?
The most recently registered devices listed for Andromeda Medizinische Systeme GmbH include ELLIPSE 4.