510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K083423Substantially Equivalent

Coloncad Api 3.1

Medicsight, London, GB / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K083423 is the FDA 510(k) clearance record for COLONCAD API 3.1, a class II device, cleared for Medicsight Plc on under FDA product code NWE (Colon Computed Tomography System, Computer Aided Detection). FDA's definition for product code NWE reads: "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". FDA records list 6 510(k) clearances for Medicsight Plc, from to . As of , FDA records show no recalls naming K083423.

Clearance record

Decision date
Received
(909 days to decision)
Product code
NWE Colon Computed Tomography System, Computer Aided Detection
Regulation
21 CFR 892.2050
Device class
Class II
Review panel
Radiology
Applicant
Medicsight Plc 66 Hammersmith Rd., London, GB
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NWE

Trailing 12 months

FDA records hold no clearances under product code NWE in the trailing twelve months.

FDA records show no clearances under product code NWE in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NWE, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260