Cleared Traditional

CardIQ Suite

K213725 · GE Medical Systems SCS · Radiology
Mar 2022
Decision
105d
Days
Class 2
Risk

About This 510(k) Submission

K213725 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 March 11, 2022, 105 days after receiving the submission on November 26, 2021. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1750.

Submission Details

510(k) Number K213725 FDA.gov
FDA Decision Cleared SESE
Date Received November 26, 2021
Decision Date March 11, 2022
Days to Decision 105 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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