Cleared Traditional

FastStroke, CT Perfusion 4D

K193289 · GE Medical Systems SCS · Radiology
Nov 2020
Decision
351d
Days
Class 2
Risk

About This 510(k) Submission

K193289 is an FDA 510(k) clearance for the FastStroke, CT Perfusion 4D, 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 November 12, 2020, 351 days after receiving the submission on November 27, 2019. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1750.

Submission Details

510(k) Number K193289 FDA.gov
FDA Decision Cleared SESE
Date Received November 27, 2019
Decision Date November 12, 2020
Days to Decision 351 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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