Independent Scintilation Imaging Systems, Inc.
CanadaFDA applicant, unverified
- Devices
- 1
What Independent Scintilation Imaging Systems, Inc. makes
Independent Scintillation Imaging Systems, Inc. manufactures the ISOCAM II, a dual-head gamma camera used for nuclear medicine imaging to capture functional images of the body for diagnostic purposes.
The ISOCAM II is classified as a Class II medical device and is listed under the FDA’s 510(k) pathway. The company is based in the United States.
Catalogue
Isocam Ii (Dual Head Gamma Camera) Ref K940487
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Independent Scintilation Imaging Systems, Inc. have in the registry?
The registry currently lists 1 device for Independent Scintilation Imaging Systems, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Independent Scintilation Imaging Systems, Inc.'s devices?
Among its 1 most recently registered device, Independent Scintilation Imaging Systems, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Independent Scintilation Imaging Systems, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Independent Scintilation Imaging Systems, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Independent Scintilation Imaging Systems, Inc. in the registry?
The most recently registered devices listed for Independent Scintilation Imaging Systems, Inc. include ISOCAM II (DUAL HEAD GAMMA CAMERA).