BunkerHill Health

8 AI-enabled medical devices from BunkerHill Health on FDA's AI-enabled device list, newest first. Includes filings under name variants as submitted to FDA.

DecisionNumberDeviceCompanyPanel
2026-03-06K260166Bunkerhill Contrast CACBunkerHill HealthRadiology
2026-03-06K260167Bunkerhill Contrast AVCBunkerHill HealthRadiology
2025-10-03K250662Bunkerhill MACBunkerhill HealthRadiology
2025-09-19K250649Bunkerhill ECG-EFBunkerHill HealthCardiovascular
2025-07-01K243779Bunkerhill Abdominal Aortic Quantification (AAQ)BunkerHill HealthRadiology
2025-04-08K242295BunkerHill BMDBunkerHill HealthRadiology
2025-01-27K243229Bunkerhill AVCBunkerHill HealthRadiology
2024-09-27K240369CAC (gated) AlgorithmBunkerHill HealthRadiology

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