Cleared Traditional

VesselIQ Xpress

K200626 · GE Medical Systems SCS · Radiology
Feb 2021
Decision
343d
Days
Class 2
Risk

About This 510(k) Submission

K200626 is an FDA 510(k) clearance for the VesselIQ Xpress, 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 February 16, 2021, 343 days after receiving the submission on March 10, 2020. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1750.

Submission Details

510(k) Number K200626 FDA.gov
FDA Decision Cleared SESE
Date Received March 10, 2020
Decision Date February 16, 2021
Days to Decision 343 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