Steinhart Medizinsysteme GmbH
GermanyFDA applicant, unverified
- Devices
- 1
What Steinhart Medizinsysteme GmbH makes
Steinhart Medizinsysteme GmbH develops HIPAX Medical Imaging Software, a specialized tool designed for processing and analyzing medical imaging data, likely supporting diagnostic workflows in radiology or orthopedics.
The company’s portfolio is regulated under FDA 510(k) clearance as Class II medical devices, indicating moderate risk and compliance with U.S. regulatory standards. The software is listed in the FDA’s 510(k) database, and the manufacturer is based in the United States.
Catalogue
Hipax Medical Imaging Software Ref K052411
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Steinhart Medizinsysteme GmbH have in the registry?
The registry currently lists 1 device for Steinhart Medizinsysteme GmbH. Devices recorded under merged duplicate company entries are counted once.
Which registries list Steinhart Medizinsysteme GmbH's devices?
Among its 1 most recently registered device, Steinhart Medizinsysteme GmbH has devices listed in FDA 510(k) (1 device).
What risk classes do Steinhart Medizinsysteme GmbH's devices fall under?
Among its 1 most recently registered device, the classes recorded for Steinhart Medizinsysteme GmbH's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Steinhart Medizinsysteme GmbH in the registry?
The most recently registered devices listed for Steinhart Medizinsysteme GmbH include HIPAX MEDICAL IMAGING SOFTWARE.