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7 FDA submission entries in this directory. This is not a count of distinct commercial offers.
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BunkerHill Health
Authorized purpose: Detect, localize, and estimate the burden of coronary artery calcification on contrast-enhanced chest CT during clinical care.
BunkerHill Health
Authorized purpose: Detect, localize, and estimate the burden of aortic valve calcification on contrast-enhanced chest CT during clinical care.
Bunkerhill Health
Authorized purpose: Detection, localization, and quantification of mitral-annulus calcification on non-gated non-contrast chest CT.
BunkerHill Health
Authorized purpose: Maximum axial abdominal aortic diameter measurement on CT exams that include L1-L5, as adjunctive unofficial information for physician review.
BunkerHill Health
Authorized purpose: Analyzes existing CT images in DICOM format from adults aged 30 years and older to estimate average areal BMD of spinal bones and flag low bone density below a preset threshold, including opportunistic scans without a phantom; it does not replace DXA or other dedicated BMD testing.
BunkerHill Health
Authorized purpose: Adjunctive opportunistic detection and quantification of aortic valve calcification during routine clinical-care chest CT review; a physician reviews the informational ROI and estimated calcium burden and decides any further action.
BunkerHill Health
Authorized purpose: Estimate the presence and quantity of coronary artery calcium in patients aged 30 years and older from non-contrast ECG-gated chest CT, with informational segmentation and quantification available to a physician for adjunctive review.