Bunkerhill Contrast CAC

Q: What is the product code of K260166?

The FDA product code is JAK – System, X-Ray, Tomography, Computed, a Class II (moderate risk) device regulated under 21 CFR 892.1750.

FDA 510(k) K260166 · BunkerHill Health

Substantially Equivalent

510(k) numberK260166

Submission

Device name: Bunkerhill Contrast CAC
Applicant: BunkerHill Health
San Francisco, CA, US
Received: January 20, 2026
Decision date: March 6, 2026
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: JAK – System, X-Ray, Tomography, Computed
Device class: Class II (moderate risk)
Regulation: 21 CFR 892.1750
Specialty: Radiology

Other 510(k)s with product code JAK

510(k)	Device	Applicant	Decision
K253836	FCT iStream Phase 2JAK · Traditional	Fujifilm Corporation	09/04/2026SE
K253450	BodyTom Elite (NL4000)JAK · Traditional	NeuroLogica Corp., a Samsung Company	07/28/2026SE
K253770	CardIQ SuiteJAK · Traditional	GE Medical Systems SCS	07/21/2026SE
K253560	Enhanced Boundary for PCCTJAK · Traditional	Ge Medical Systems, LLC	06/24/2026SE
K253026	Respiratory Gating for Scanners (2.1)JAK · Traditional	Varian Medical Systems, Inc.	06/04/2026SE
K253596	Aquilion ONE (TSX-308A/TSX-306A) V2.0JAK · Traditional	Canon Medical Systems Corporation	05/20/2026SE
K253649	Spectral CT Verida FamilyJAK · Traditional	Philips Medical Systems Technologies , Ltd.	03/27/2026SE
K253686	True Definition DLJAK · Traditional	Ge Healthcare Japan Corporation	03/23/2026SE
K252992	CT Rembra RT; CT Areta RT; CT RembraJAK · Traditional	Philips Healthcare (Suzhou) Co., Ltd.	03/23/2026SE
K253574	SOMATOM X.cite; SOMATOM X.ceedJAK · Traditional	Siemens Medical Solutions USA, Inc.	03/20/2026SE

510(k)	Device	Decision
K260167	Bunkerhill Contrast AVCJAK · Traditional	03/06/2026SE
K250662	Bunkerhill MACJAK · Traditional	10/03/2025SE
K250649	Bunkerhill ECG-EFQYE · Traditional	09/19/2025SE
K243779	Bunkerhill Abdominal Aortic Quantification (AAQ)QIH · Traditional	07/01/2025SE
K242295	BunkerHill BMDKGI · Traditional	04/08/2025SE
K243229	Bunkerhill AVCJAK · Traditional	01/27/2025SE
K240369	CAC (gated) AlgorithmJAK · Traditional	09/27/2024SE

Questions and answers

When was Bunkerhill Contrast CAC cleared by the FDA?

Bunkerhill Contrast CAC (K260166) received a 510(k) decision of Substantially Equivalent on March 6, 2026, 45 days after the submission was received.

What is the product code of K260166?

The FDA product code is JAK – System, X-Ray, Tomography, Computed, a Class II (moderate risk) device regulated under 21 CFR 892.1750.