Summit Nuclear
Country not established
- Devices
- 6
What Summit Nuclear makes
Summit Nuclear manufactures gamma camera systems, including the VISION FX 40 & 80 Series, VISION 1024RZ, and T-22 Series, designed for nuclear medicine imaging. Their portfolio also includes dedicated neuroimaging systems like the VISION Neurospect and standalone nuclear medicine computer systems. These devices are used for diagnostic imaging in procedures such as PET and SPECT scans.
The company’s gamma cameras and imaging systems are classified under FDA categories Class I and Class II, with relevant devices listed via the 510(k) pathway. Their products are intended for use in the United States, where regulatory compliance aligns with FDA requirements for medical imaging devices.
Catalogue
Vision Fx 40 & 80 Series Gamma Camera Ref K935273
Regimes: 510(k) Registry: 510(k)Summit Nuclear Vision Neurospect Ref K920958
Regimes: 510(k) Registry: 510(k)Summit Nuclear Vision 1024RZ Gamma Camera System Ref K922427
Regimes: 510(k) Registry: 510(k)Vision (Nuclear Medicine Computer) Ref K912573
Regimes: 510(k) Registry: 510(k)Summit Nuclear Vision T-22 Gamma Camera System Ref K922426
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Summit Nuclear have in the registry?
The registry currently lists 6 devices for Summit Nuclear. Devices recorded under merged duplicate company entries are counted once.
Which registries list Summit Nuclear's devices?
Among its 6 most recently registered devices, Summit Nuclear has devices listed in FDA 510(k) (6 devices).
What risk classes do Summit Nuclear's devices fall under?
Among its 6 most recently registered devices, the classes recorded for Summit Nuclear's devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Summit Nuclear in the registry?
The most recently registered devices listed for Summit Nuclear include VISION FX 40 & 80 SERIES GAMMA CAMERA, SUMMIT NUCLEAR VISION NEUROSPECT, SUMMIT NUCLEAR VISION 1024RZ GAMMA CAMERA SYSTEM and VISION (NUCLEAR MEDICINE COMPUTER).