Company profile

BunkerHill Health

BunkerHill Health has 8 AI-enabled medical devices on the FDA list. The first decision was on September 27, 2024 and the most recent on March 6, 2026 (Bunkerhill Contrast CAC). Its most common review panel is Radiology (7 devices).

8AI devices

2024First decision

2026Latest decision

2Specialties

Per year

202420252026

BunkerHill Health AI devices per year: 2024 1, 2025 5, 2026 2

By specialty

Radiology7
Cardiovascular1

Related guides

Top radiology devices

Timeline

March 6, 2026 · 510(k) K260166Bunkerhill Contrast CAC · Radiology · JAK
March 6, 2026 · 510(k) K260167Bunkerhill Contrast AVC · Radiology · JAK
October 3, 2025 · 510(k) K250662Bunkerhill MAC · Radiology · JAK
September 19, 2025 · 510(k) K250649Bunkerhill ECG-EF · Cardiovascular · QYE
July 1, 2025 · 510(k) K243779Bunkerhill Abdominal Aortic Quantification (AAQ) · Radiology · QIH
April 8, 2025 · 510(k) K242295BunkerHill BMD · Radiology · KGI
January 27, 2025 · 510(k) K243229Bunkerhill AVC · Radiology · JAK
September 27, 2024 · 510(k) K240369CAC (gated) Algorithm · Radiology · JAK