Eagle Heart Imaging, LLC
Country not established
- Devices
- 1
What Eagle Heart Imaging, LLC makes
Eagle Heart Imaging, LLC manufactures the MULTI-SPECT, a device designed for cardiac imaging and spectral analysis to assess myocardial perfusion and tissue characterization.
The company’s portfolio is regulated under FDA Class II devices and requires 510(k) clearance for market authorisation. The company is based in the United States.
Catalogue
Multi-Spect Ref K073021
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Eagle Heart Imaging, LLC have in the registry?
The registry currently lists 1 device for Eagle Heart Imaging, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Eagle Heart Imaging, LLC's devices?
Among its 1 most recently registered device, Eagle Heart Imaging, LLC has devices listed in FDA 510(k) (1 device).
What risk classes do Eagle Heart Imaging, LLC's devices fall under?
Among its 1 most recently registered device, the classes recorded for Eagle Heart Imaging, LLC's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Eagle Heart Imaging, LLC in the registry?
The most recently registered devices listed for Eagle Heart Imaging, LLC include MULTI-SPECT.