Cleared Traditional

Bunkerhill MAC

K250662 · BunkerHill Health · Radiology
Oct 2025
Decision
212d
Days
Class 2
Risk

About This 510(k) Submission

K250662 is an FDA 510(k) clearance for the Bunkerhill MAC, 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 October 3, 2025, 212 days after receiving the submission on March 5, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1750.

Submission Details

510(k) Number K250662 FDA.gov
FDA Decision Cleared SESE
Date Received March 05, 2025
Decision Date October 03, 2025
Days to Decision 212 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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