Is2 Research, Inc.
CanadaFDA applicant, unverified
- Devices
- 7
What Is2 Research, Inc. makes
Is2 Research, Inc. manufactures nuclear medicine imaging devices, including the NUCAMMA BI90, NUCAMMA R+, and NUCAMMA RX, which are designed for cardiac imaging. The company also produces mobile imaging systems like the Mobile Single Circular Camera (MSC), Mobile Digital Cardiac Camera (MDCC), and Mobile Compact Digital Cardiac Camera, as well as the BCC Gamma Camera for diagnostic purposes.
These devices are classified as Class II under FDA regulations and are supported by 510(k) clearance records. The company is based in the United States.
Catalogue
Nucamma BI90 Ref K003882
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Nucamma R+ Ref K982044
Regimes: 510(k) Registry: 510(k)Modification To: Nucamma Rx Ref K032779
Regimes: 510(k) Registry: 510(k)Nucamma Rx Ref K982045
Regimes: 510(k) Registry: 510(k)Mobile Compact Digital Cardiac Camera Ref K040057
Regimes: 510(k) Registry: 510(k)Bcc Gamma Camera Ref K013667
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Is2 Research, Inc. have in the registry?
The registry currently lists 7 devices for Is2 Research, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Is2 Research, Inc.'s devices?
Among its 7 most recently registered devices, Is2 Research, Inc. has devices listed in FDA 510(k) (7 devices).
What risk classes do Is2 Research, Inc.'s devices fall under?
Among its 7 most recently registered devices, the classes recorded for Is2 Research, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Is2 Research, Inc. in the registry?
The most recently registered devices listed for Is2 Research, Inc. include NUCAMMA BI90, MOBILE SINGLE CIRCULAR CAMERA (MSC) & MOBILE DIGITAL CARDIAC CAMERA (MDCC), NUCAMMA R+ and MODIFICATION TO: NUCAMMA RX.