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510(k) K243229

Bunkerhill AVC by BunkerHill Health — Product Code JAK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 27, 2025
Date Received
October 8, 2024
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

  • K260167 — Bunkerhill Contrast AVC (March 6, 2026)
  • 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)
  • 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)
  • K260167 — Bunkerhill Contrast AVC (March 6, 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)