BunkerHill Health
Country not established FDA FEI 3027245002
- Devices
- 13
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA FEI
What BunkerHill Health makes
BunkerHill Health manufactures software-based medical imaging tools for cardiac and vascular analysis, including automated algorithms for coronary artery calcium scoring (CAC) and aortic valve calcification (AVC) assessment. Their portfolio also includes solutions for measuring left ventricular ejection fraction (ECG-EF) and quantifying abdominal aortic aneurysms (AAQ), as well as bone mineral density (BMD) evaluation. These tools integrate with existing imaging systems to provide quantitative measurements and diagnostic support.
The company’s devices are classified as Class II under FDA regulations and are authorised through the 510(k) clearance pathway. Their products are listed in the FDA’s 510(k) database, reflecting compliance with US medical device regulations. The manufacturer operates from the United States.
Catalogue
Search and filter all 13 devicesCompany details
- FDA FEI number
- 3027245002
- Address
- 144 2nd St Ste 100, San Francisco, CA, 94105
Frequently asked questions
How many devices does BunkerHill Health have in the registry?
The registry currently lists 13 devices for BunkerHill Health. Devices recorded under merged duplicate company entries are counted once.
Which registries list BunkerHill Health's devices?
Among its 13 most recently registered devices, BunkerHill Health has devices listed in FDA 510(k) (8 devices) and FDA GUDID (5 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do BunkerHill Health's devices fall under?
Among its 13 most recently registered devices, the classes recorded for BunkerHill Health's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from BunkerHill Health in the registry?
The most recently registered devices listed for BunkerHill Health include iCAC Device 1.0.0, CAC (Gated) Algorithm 1, Bunkerhill Contrast AVC 1.0.0 and Bunkerhill ECG-EF 1.0.0.