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The Tracker / August 2026 / K260343

510(k) cleared

Carescape Canvas 1000; Carescape Canvas Smart Display

GE Healthcare Finland Oy · Aug 28, 2026 · K260343

FDA cleared the Carescape Canvas 1000; Carescape Canvas Smart Display from GE Healthcare Finland Oy on Aug 28, 2026 under K260343, a traditional 510(k). The device falls under product code MHX, Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms), regulated at 21 CFR 870.1025 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Feb 2, 2026. The decision came 207 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for GE Healthcare Finland Oy in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260343?

K260343 is the FDA 510(k) for Carescape Canvas 1000; Carescape Canvas Smart Display, submitted by GE Healthcare Finland Oy. FDA's decision date was Aug 28, 2026, under product code MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)).

Who makes the Carescape Canvas 1000; Carescape Canvas Smart Display?

GE Healthcare Finland Oy, based in Helsinki, is the applicant of record for K260343.

How long did the K260343 review take?

FDA received the submission on Feb 2, 2026 and issued its decision on Aug 28, 2026, 207 days later.

← All decisions in August 2026