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510(k) K032823

MEDICHEART, MODEL RELEASE 1 by Medicsight — Product Code JAK

K032823 is an FDA 510(k) premarket notification submitted by Medicsight for the device "MEDICHEART, MODEL RELEASE 1". The FDA issued a decision of Substantially Equivalent on November 10, 2003. The device falls under product code JAK (System, X-Ray, Tomography, Computed), a Class II device regulated under 21 CFR 892.1750. Medicsight has at least 5 other 510(k) clearances on record.

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

  • K261229 — SCENARIA View Phase 6.0 (September 18, 2026)
  • K253836 — FCT iStream Phase 2 (September 4, 2026)
  • K253450 — BodyTom Elite (NL4000) (July 28, 2026)
  • K253770 — CardIQ Suite (July 21, 2026)
  • K253560 — Enhanced Boundary for PCCT (June 24, 2026)
  • K253026 — Respiratory Gating for Scanners (2.1) (June 4, 2026)
  • K253596 — Aquilion ONE (TSX-308A/TSX-306A) V2.0 (May 20, 2026)
  • K253649 — Spectral CT Verida Family (March 27, 2026)
  • K252992 — CT Rembra RT; CT Areta RT; CT Rembra (March 23, 2026)
  • K253686 — True Definition DL (March 23, 2026)

FDA data resources