Isirona, LLC
Country not established
- Devices
- 1
What Isirona, LLC makes
Isirona, LLC manufactures the ISIRONA MAGELLAN, a medical imaging device designed for intravascular ultrasound (IVUS) imaging to visualize blood vessels and assess plaque buildup during coronary and peripheral procedures.
The ISIRONA MAGELLAN is classified as a Class II device under FDA regulations and is listed in the FDA’s 510(k) clearance registry. The company is based in the United States.
Catalogue
Isirona Magellan Ref K130707
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Isirona, LLC have in the registry?
The registry currently lists 1 device for Isirona, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Isirona, LLC's devices?
Among its 1 most recently registered device, Isirona, LLC has devices listed in FDA 510(k) (1 device).
What risk classes do Isirona, LLC's devices fall under?
Among its 1 most recently registered device, the classes recorded for Isirona, LLC's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Isirona, LLC in the registry?
The most recently registered devices listed for Isirona, LLC include ISIRONA MAGELLAN.