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510(k) K260167

Bunkerhill Contrast AVC by BunkerHill Health — Product Code JAK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 6, 2026
Date Received
January 20, 2026
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Tomography, Computed
Device Class
Class II
Regulation Number
892.1750
Review Panel
RA
Submission Type

Other clearances by BunkerHill Health

  • K260166 — Bunkerhill Contrast CAC (March 6, 2026)
  • K250662 — Bunkerhill MAC (October 3, 2025)
  • K250649 — Bunkerhill ECG-EF (September 19, 2025)
  • K243779 — Bunkerhill Abdominal Aortic Quantification (AAQ) (July 1, 2025)
  • K242295 — BunkerHill BMD (April 8, 2025)
  • K243229 — Bunkerhill AVC (January 27, 2025)
  • K240369 — CAC (gated) Algorithm (September 27, 2024)

Other clearances for product code JAK

  • K260078 — Aquilion ServeSP (TSX-307B) V2.0 (March 13, 2026)
  • K252249 — Extremity CT Imaging System (March 13, 2026)
  • K260166 — Bunkerhill Contrast CAC (March 6, 2026)
  • K260169 — AV Cardiac CT (March 5, 2026)
  • K253173 — uCT 780 with uWS-CT-Dual Energy Analysis (January 20, 2026)
  • K252217 — CT VScore+ (November 28, 2025)
  • K251805 — syngo.CT Dual Energy (October 15, 2025)
  • K250662 — Bunkerhill MAC (October 3, 2025)
  • K250766 — LungQ 4 (October 2, 2025)
  • K251645 — Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B, INFX-8000C/S (September 26, 2025)