CAC (gated) Algorithm— 510(k) K240369

Name: FDA 510(k) clearance K240369
Creator: U.S. Food and Drug Administration
Published: 2024-09-27

Substantially Equivalent

BunkerHill Health

FDA 510(k) clearance K240369 for CAC (gated) Algorithm, Substantially Equivalent on 2024-09-27. Applicant: BunkerHill Health. Device class: 2.

Clearance details

Applicant: BunkerHill Health
Product code: Code JAK
Device class: Class 2
Regulation: 21 CFR 892.1750
Advisory panel: Radiology
Date received: 2024-02-07
Decision date: 2024-09-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Francisco, CA, US

Download summary PDF View on FDA.gov ↗

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More clearances from BunkerHill Health

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K260166 — Bunkerhill Contrast CAC2026-03-06
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K250662 — Bunkerhill MAC2025-10-03
K250649 — Bunkerhill ECG-EF2025-09-19
K243779 — Bunkerhill Abdominal Aortic Quantification (AAQ)2025-07-01

Adverse events under product code JAK

product code JAK

Death: 27
Injury: 571
Malfunction: 779
Total: 1,377

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.