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510(k) K042674

COLON CAR 1.2 by Medicsight — Product Code NWE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 19, 2004
Date Received
September 29, 2004
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Colon Computed Tomography System, Computer Aided Detection
Device Class
Class II
Regulation Number
892.2050
Review Panel
RA
Submission Type

To assist radiologists in the review of multi-slice computed tomography (msct) exams of the colon and highlight potential polyps that the radiologist should review.

Other clearances by Medicsight

  • K083423 — COLONCAD API 3.1 (May 17, 2011)
  • K041807 — LUNG CAR 1.1 (July 22, 2004)
  • K033412 — MEDICLUNG, RELEASE 1 (December 30, 2003)
  • K032823 — MEDICHEART, MODEL RELEASE 1 (November 10, 2003)
  • K033102 — MEDIC COLON MODEL, RELEASE 1 (November 5, 2003)

Other clearances for product code NWE

  • K140920 — SYNGO.CT COLONOGRAPHY (December 3, 2014)
  • K083423 — COLONCAD API 3.1 (May 17, 2011)
  • K042605 — COLONGRAPHY SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY (October 8, 2004)