Cleared Traditional

K213279 - NovaGuide 2 Intelligent Ultrasound

K213279 is an FDA 510(k) clearance for NovaGuide 2 Intelligent Ultrasound, manufactured by Novasignal Corporation. The device is a Class 2 Radiology device with product code IYN cleared through the Traditional 510(k) pathway after a 152-day FDA review.

K213279 · Novasignal Corporation · Radiology device
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Mar 2022
Decision
152d
Days
Class 2
Risk

K213279 is an FDA 510(k) clearance for the NovaGuide 2 Intelligent Ultrasound. 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 Novasignal Corporation (Los Angeles, US). The FDA issued a Cleared decision on March 2, 2022 after a review of 152 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 Novasignal Corporation devices

FDA 510(k) Submission Details - K213279

510(k) Number K213279 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 2021
Decision Date March 02, 2022
Days to Decision 152 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
45d slower than avg
Panel avg: 107d · This submission: 152d
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 892
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K213279.
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