Cleared Traditional

CardIQ Suite

K243672 · GE Medical Systems SCS · Radiology
Jun 2025
Decision
203d
Days
Class 2
Risk

About This 510(k) Submission

K243672 is an FDA 510(k) clearance for the CardIQ Suite, a System, X-ray, Tomography, Computed (Class II — Special Controls, product code JAK), submitted by GE Medical Systems SCS (Buc, FR). The FDA issued a Cleared decision on June 18, 2025, 203 days after receiving the submission on November 27, 2024. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1750.

Submission Details

510(k) Number K243672 FDA.gov
FDA Decision Cleared SESE
Date Received November 27, 2024
Decision Date June 18, 2025
Days to Decision 203 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code JAK — System, X-ray, Tomography, Computed
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1750

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