Cleared Traditional

K160350 - ECG CT Gating Device

K160350 is an FDA 510(k) clearance for ECG CT Gating Device, manufactured by Neocoil, LLC. The device is a Class 2 Radiology device with product code JAK cleared through the Traditional 510(k) pathway after a 129-day FDA review.

K160350 · Neocoil, LLC · Radiology device
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Jun 2016
Decision
129d
Days
Class 2
Risk

K160350 is an FDA 510(k) clearance for the ECG CT Gating Device. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by Neocoil, LLC (Pewaukee, US). The FDA issued a Cleared decision on June 16, 2016 after a review of 129 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 Neocoil, LLC devices

FDA 510(k) Submission Details - K160350

510(k) Number K160350 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 2016
Decision Date June 16, 2016
Days to Decision 129 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
22d slower than avg
Panel avg: 107d · This submission: 129d
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 637
Devices cleared under the same product code (JAK) and FDA review panel - the closest regulatory comparables to K160350.
Philips Ingenuity CT
K160743 · Philips Medical Systems (Cleveland), Inc. · Aug 2016
Aquilion ONE Vision with FIRST 2.0 (CCRS-001B) V7.4
K161009 · Toshibamedical Systems Corporation · Jul 2016
ADMIRE
K153360 · Siemens Medi Cal Solutions, Inc. · Jun 2016
Aquilion ONE (TSX-305A/3) V7.3
K160587 · Toshibamedical Systems Corporation · Jun 2016
Philips Multislice CT System with Low Dose CT Lung Cancer
K153444 · Philips Medical Systems (Cleveland), Inc. · Apr 2016
Aquilion Lightning, TSX-035A/4 and /5, V7.0
K153263 · Toshibamedical Systems Corporation · Apr 2016