Cleared Traditional

Bunkerhill Contrast AVC

K260167 · BunkerHill Health · Radiology
Mar 2026
Decision
45d
Days
Class 2
Risk

About This 510(k) Submission

K260167 is an FDA 510(k) clearance for the Bunkerhill Contrast 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 March 6, 2026, 45 days after receiving the submission on January 20, 2026. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1750.

Submission Details

510(k) Number K260167 FDA.gov
FDA Decision Cleared SESE
Date Received January 20, 2026
Decision Date March 06, 2026
Days to Decision 45 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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