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510(k) K033102

MEDIC COLON MODEL, RELEASE 1 by Medicsight — Product Code JAK

K033102 is an FDA 510(k) premarket notification submitted by Medicsight for the device "MEDIC COLON MODEL, RELEASE 1". The FDA issued a decision of Substantially Equivalent on November 5, 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 5, 2003
Date Received
September 29, 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)
  • K032823 — MEDICHEART, MODEL RELEASE 1 (November 10, 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