Cleared Traditional

CardIQ Flow

K192277 · GE Medical Systems SCS · Radiology
Feb 2020
Decision
176d
Days
Class 2
Risk

About This 510(k) Submission

K192277 is an FDA 510(k) clearance for the CardIQ Flow, a System, Tomography, Computed, Emission (Class II — Special Controls, product code KPS), submitted by GE Medical Systems SCS (Buc, FR). The FDA issued a Cleared decision on February 14, 2020, 176 days after receiving the submission on August 22, 2019. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1200.

Submission Details

510(k) Number K192277 FDA.gov
FDA Decision Cleared SESE
Date Received August 22, 2019
Decision Date February 14, 2020
Days to Decision 176 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code KPS — System, Tomography, Computed, Emission
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1200

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