Bunkerhill Contrast CAC
K-Number: K260166 · 2026-03-06
ApplicantBunkerHill Health
Decision Date2026-03-06
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Bunkerhill Contrast CAC is a medical device manufactured by BunkerHill Health. It received FDA 510(k) clearance on 2026-03-06 under approval number K260166. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Bunkerhill Contrast CAC?
Bunkerhill Contrast CAC is a medical device that received FDA 510(k) clearance on 2026-03-06. It is manufactured by BunkerHill Health. The 510(k) number is K260166.
When was Bunkerhill Contrast CAC approved by the FDA?
Bunkerhill Contrast CAC received FDA 510(k) clearance on 2026-03-06, under approval number K260166.
What company makes Bunkerhill Contrast CAC?
Bunkerhill Contrast CAC is manufactured by BunkerHill Health.
What is the FDA product code for Bunkerhill Contrast CAC?
The FDA product code for Bunkerhill Contrast CAC is JAK.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.