Home / 510(k) Clearances / K083423

510(k) K083423

COLONCAD API 3.1 by Medicsight Plc — Product Code NWE

K083423 is an FDA 510(k) premarket notification submitted by Medicsight Plc for the device "COLONCAD API 3.1". The FDA issued a decision of Substantially Equivalent on May 17, 2011. The device falls under product code NWE (Colon Computed Tomography System, Computer Aided Detection), a Class II device regulated under 21 CFR 892.2050. Medicsight Plc has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 17, 2011
Date Received
November 19, 2008
Clearance Type
Traditional
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 Plc

  • 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)
  • K033102 — MEDIC COLON MODEL, RELEASE 1 (November 5, 2003)

Other clearances for product code NWE

  • K140920 — SYNGO.CT COLONOGRAPHY (December 3, 2014)
  • K042674 — COLON CAR 1.2 (October 19, 2004)
  • K042605 — COLONGRAPHY SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY (October 8, 2004)

FDA data resources