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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is BunkerHill Health. It received FDA 510(k) clearance on 2026-03-06 under 510(k) 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. The listed applicant is BunkerHill Health. The 510(k) number is K260166.

When did Bunkerhill Contrast CAC receive FDA 510(k) clearance?

Bunkerhill Contrast CAC received FDA 510(k) clearance on 2026-03-06, under 510(k) number K260166.

Who is the listed applicant for Bunkerhill Contrast CAC?

The FDA 510(k) record lists BunkerHill Health as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Bunkerhill Contrast CAC?

The FDA product code for Bunkerhill Contrast CAC is JAK.

Other records listing BunkerHill Health as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: JAK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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.

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