Cleared Traditional

CAC (gated) Algorithm

K240369 · BunkerHill Health · Radiology
Sep 2024
Decision
233d
Days
Class 2
Risk

About This 510(k) Submission

K240369 is an FDA 510(k) clearance for the CAC (gated) Algorithm, a System, X-ray, Tomography, Computed (Class II — Special Controls, product code JAK), submitted by BunkerHill Health (San Francisco, US). The FDA issued a Cleared decision on September 27, 2024, 233 days after receiving the submission on February 7, 2024. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1750.

Submission Details

510(k) Number K240369 FDA.gov
FDA Decision Cleared SESE
Date Received February 07, 2024
Decision Date September 27, 2024
Days to Decision 233 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code JAK — System, X-ray, Tomography, Computed
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1750

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