Cleared Traditional

K162372 - QT Ultrasound Breast Scanner-1

K162372 is the FDA 510(k) clearance for QT Ultrasound Breast Scanner-1 by Qt Ultrasound, LLC. It is a Class 2 Radiology device (product code IYO) cleared through the Traditional 510(k) pathway after a 286-day FDA review.

K162372 · Qt Ultrasound, LLC · Radiology device
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Jun 2017
Decision
286d
Days
Class 2
Risk

K162372 is an FDA 510(k) clearance for the QT Ultrasound Breast Scanner-1. Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by Qt Ultrasound, LLC (Novato, US). The FDA issued a Cleared decision on June 6, 2017 after a review of 286 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1560 - 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 Qt Ultrasound, LLC devices

Submission Details

510(k) Number K162372 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 2016
Decision Date June 06, 2017
Days to Decision 286 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
179d slower than avg
Panel avg: 107d · This submission: 286d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IYO System, Imaging, Pulsed Echo, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1560
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 - IYO System, Imaging, Pulsed Echo, Ultrasonic

All 388
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