Cleared Traditional

CardIQ Suite

K233731 · GE Medical Systems SCS · Radiology
Aug 2024
Decision
254d
Days
Class 2
Risk

About This 510(k) Submission

K233731 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 August 1, 2024, 254 days after receiving the submission on November 21, 2023. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1750.

Submission Details

510(k) Number K233731 FDA.gov
FDA Decision Cleared SESE
Date Received November 21, 2023
Decision Date August 01, 2024
Days to Decision 254 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

Similar Devices — JAK System, X-ray, Tomography, Computed

All 811
Extremity CT Imaging System
K252249 · Mars Bioimaging , Ltd. · Mar 2026
Aquilion ServeSP (TSX-307B) V2.0
K260078 · Canon Medical Systems Corporation · Mar 2026
Bunkerhill Contrast CAC
K260166 · BunkerHill Health · Mar 2026
Bunkerhill Contrast AVC
K260167 · BunkerHill Health · Mar 2026
AV Cardiac CT
K260169 · Philips Medical Systems Nederland B.V. · Mar 2026
uCT 780 with uWS-CT-Dual Energy Analysis
K253173 · Shanghai United Imaging Healthcare Co., Ltd. · Jan 2026