Home / 510(k) Clearances / K032823

510(k) K032823

MEDICHEART, MODEL RELEASE 1 by Medicsight — Product Code JAK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 10, 2003
Date Received
September 10, 2003
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 Medicsight

  • K083423 — COLONCAD API 3.1 (May 17, 2011)
  • K042674 — COLON CAR 1.2 (October 19, 2004)
  • K041807 — LUNG CAR 1.1 (July 22, 2004)
  • K033412 — MEDICLUNG, RELEASE 1 (December 30, 2003)
  • K033102 — MEDIC COLON MODEL, RELEASE 1 (November 5, 2003)

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)