Cleared Traditional

K172059 - LinkQuest Diagnostic Ultrasound System ...

K172059 is an FDA 510(k) clearance for LinkQuest Diagnostic Ultrasound System ..., manufactured by Linkquest, Inc.. The device is a Class 2 Radiology device with product code IYN cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K172059 · Linkquest, Inc. · Radiology device
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Oct 2017
Decision
90d
Days
Class 2
Risk

K172059 is an FDA 510(k) clearance for the LinkQuest Diagnostic Ultrasound System model SQ860. 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 Linkquest, Inc. (San Diego, US). The FDA issued a Cleared decision on October 5, 2017 after a review of 90 days - within the typical 510(k) review window.

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 Linkquest, Inc. devices

FDA 510(k) Submission Details - K172059

510(k) Number K172059 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 2017
Decision Date October 05, 2017
Days to Decision 90 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
17d faster than avg
Panel avg: 107d · This submission: 90d
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 922
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K172059.
Vivid E80, Vivid E90, Vivid E95
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