Cleared Traditional

Bunkerhill AVC

K243229 · BunkerHill Health · Radiology
Jan 2025
Decision
111d
Days
Class 2
Risk

About This 510(k) Submission

K243229 is an FDA 510(k) clearance for the Bunkerhill AVC, 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 January 27, 2025, 111 days after receiving the submission on October 8, 2024. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1750.

Submission Details

510(k) Number K243229 FDA.gov
FDA Decision Cleared SESE
Date Received October 08, 2024
Decision Date January 27, 2025
Days to Decision 111 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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