Cleared Traditional

K200626 - VesselIQ Xpress

K200626 is an FDA 510(k) clearance for VesselIQ Xpress, manufactured by GE Medical Systems SCS. The device is a Class 2 Radiology device with product code JAK cleared through the Traditional 510(k) pathway after a 343-day FDA review.

K200626 · GE Medical Systems SCS · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2021
Decision
343d
Days
Class 2
Risk

K200626 is an FDA 510(k) clearance for the VesselIQ Xpress. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by GE Medical Systems SCS (Buc, FR). The FDA issued a Cleared decision on February 16, 2021 after a review of 343 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1750 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all GE Medical Systems SCS devices

FDA 510(k) Submission Details - K200626

510(k) Number K200626 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
236d slower than avg
Panel avg: 107d · This submission: 343d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JAK Device Classification - Class 2, Special Controls

Product Code JAK System, X-ray, Tomography, Computed
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1750
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - JAK System, X-ray, Tomography, Computed

All 639
Devices cleared under the same product code (JAK) and FDA review panel - the closest regulatory comparables to K200626.
Aquilion ONE (TSX-306A/3) V10.4 with Spectral Imaging System
K203225 · Canon Medical Systems Corporation · Mar 2021
MaxFOV 2
K203617 · Ge Medical Systems, LLC · Mar 2021
Spectral CT
K203020 · Philips Medical Systems Nederland B.V. · Feb 2021
CTxx85 CT Scanner
K201231 · Analogic Corporation · Feb 2021
Aquilion Lightning (TSX-036A/7) V10.2 with AiCE-i
K201836 · Canon Medical Systems Corporation · Jan 2021
OmniTom Elite
K202526 · Neurologica Corporation, A Subsidiary of Samsung Electronics · Dec 2020