Cleared Traditional

K172056 - InnoSight Diagnostic Ultrasound System

K172056 is the FDA 510(k) clearance for InnoSight Diagnostic Ultrasound System by Qisda Corporation. It is a Class 2 Radiology device (product code IYO) cleared through the Traditional 510(k) pathway after a 160-day FDA review.

K172056 · Qisda Corporation · Radiology device
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Dec 2017
Decision
160d
Days
Class 2
Risk

K172056 is an FDA 510(k) clearance for the InnoSight Diagnostic Ultrasound System. Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by Qisda Corporation (Taoyuan City, TW). The FDA issued a Cleared decision on December 13, 2017 after a review of 160 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 Qisda Corporation devices

Submission Details

510(k) Number K172056 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 2017
Decision Date December 13, 2017
Days to Decision 160 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
53d slower than avg
Panel avg: 107d · This submission: 160d
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
Devices cleared under the same product code (IYO) and FDA review panel - the closest regulatory comparables to K172056.
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