Ultralinq Healthcare Solutions, Inc.
Country not established
- Devices
- 3
What Ultralinq Healthcare Solutions, Inc. makes
Ultralinq Healthcare Solutions, Inc. manufactures the UltraLinq device, a medical imaging system designed for real-time fluoroscopy and interventional radiology procedures. This system is intended for use in diagnostic and therapeutic procedures, including vascular interventions and orthopedic surgeries, where continuous X-ray imaging is required.
The UltraLinq device is classified as a Class II medical device under FDA regulations and has undergone the 510(k) premarket notification process. It is listed in the FDA’s 510(k) database, adhering to U.S. regulatory standards for medical imaging equipment. The company is headquartered in the United States.
Catalogue
- Registry: GUDID
- Registry: GUDID
UltraLinq Ref K143176
Regimes: 510(k) Registry: 510(k)
Company details
- DUNS number
- 830536756
- [email protected]
- Phone
- 1-800-227-2956
Frequently asked questions
How many devices does ULTRALINQ HEALTHCARE SOLUTIONS, INC. have in the registry?
The registry currently lists 3 devices for ULTRALINQ HEALTHCARE SOLUTIONS, INC.. Devices recorded under merged duplicate company entries are counted once.
Which registries list ULTRALINQ HEALTHCARE SOLUTIONS, INC.'s devices?
Among its 3 most recently registered devices, ULTRALINQ HEALTHCARE SOLUTIONS, INC. has devices listed in FDA 510(k) (1 device) and FDA GUDID (2 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do ULTRALINQ HEALTHCARE SOLUTIONS, INC.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for ULTRALINQ HEALTHCARE SOLUTIONS, INC.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from ULTRALINQ HEALTHCARE SOLUTIONS, INC. in the registry?
The most recently registered devices listed for ULTRALINQ HEALTHCARE SOLUTIONS, INC. include UltraLinq 58.13, UpLinq UP_001 and UltraLinq.