Naviscan, Inc.
Country not established
- Devices
- 1
What Naviscan, Inc. makes
Naviscan, Inc. manufactures the PEMFlex Solo II, a high-resolution positron emission tomography (PET) scanner designed for medical imaging applications. This device is intended for use in detecting and evaluating metabolic activity within the body, commonly employed in oncology and other diagnostic procedures.
The PEMFlex Solo II is classified as a Class II medical device in the United States and is listed under the FDA’s 510(k) pathway. The company is based in the US.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Naviscan, Inc. have in the registry?
The registry currently lists 1 device for Naviscan, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Naviscan, Inc.'s devices?
Among its 1 most recently registered device, Naviscan, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Naviscan, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Naviscan, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Naviscan, Inc. in the registry?
The most recently registered devices listed for Naviscan, Inc. include NAVISCAN PEMFLEX SOLO II HIGH RESOLUTION PET SCANNER.