Cleared Traditional

K141462 - VARIA-NCI

K141462 is an FDA 510(k) clearance for VARIA-NCI, manufactured by Neurochaos Solutions, Inc.. The device is a Class 2 Radiology device with product code IYN cleared through the Traditional 510(k) pathway after a 169-day FDA review.

K141462 · Neurochaos Solutions, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2014
Decision
169d
Days
Class 2
Risk

K141462 is an FDA 510(k) clearance for the VARIA-NCI. Classified as System, Imaging, Pulsed Doppler, Ultrasonic within the IYN classification (a category covering pulsed Doppler and ultrasound imaging systems), Class II - Special Controls.

Submitted by Neurochaos Solutions, Inc. (Austin, US). The FDA issued a Cleared decision on November 19, 2014 after a review of 169 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1550 - 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 Neurochaos Solutions, Inc. devices

FDA 510(k) Submission Details - K141462

510(k) Number K141462 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 2014
Decision Date November 19, 2014
Days to Decision 169 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
62d slower than avg
Panel avg: 107d · This submission: 169d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IYN Device Classification - Class 2, Special Controls

Product Code IYN System, Imaging, Pulsed Doppler, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1550
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 - IYN System, Imaging, Pulsed Doppler, Ultrasonic

All 923
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K141462.
WS80A Diagnostic Ultrasound System
K143089 · Samsung Medison Co., Ltd. · Nov 2014
ULTRASOUND SYSTEM SONIMAGE HS1, LINEAR PROBE L18-4, CONVEX PROBE C5-2
K142197 · Konica Minolta, Inc. · Nov 2014
Xario 200, V3.0
K143027 · Toshibamedical Systems Corporation · Nov 2014
Xario 100, V3.0
K143046 · Toshibamedical Systems Corporation · Nov 2014
APLIO 500/400/300 DIAGNOSTIC ULTRASOUND SYSTEM, V5.0
K141459 · Toshibamedical Systems Corporation · Oct 2014
E-CUBE 5
K142733 · Alpinion Medical Systems Co., Ltd. · Oct 2014