FDA-cleared K203256
Imbio RV/LV Software
Imbio, LLC
Authorized purpose: Measures maximal right- and left-ventricular diameters and reports their ratio.
- Modality
- CT/CTA
- Anatomy
- Heart/Cardiovascular
- Decision
- 2021-03-09
Vendor
Imbio, LLC
2 FDA submission entries in this directory. This is not a count of distinct commercial offers.
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FDA-cleared K141069
Lung Density Analysis
IMBIO LLC
Authorized purpose: Quantitative support for physician diagnosis, documentation, and follow-up examination of pulmonary tissue images and abnormalities from CT thoracic datasets
- Modality
- CT/CTA
- Anatomy
- Pulmonary tissue/lungs
- Decision
- 2014-09-17