Cleared Traditional

K173486 - NTU-USB Ultrasound USB Box

K173486 is the FDA 510(k) clearance for NTU-USB Ultrasound USB Box by National Taiwan University. It is a Class 2 Radiology device (product code IYN) cleared through the Traditional 510(k) pathway after a 240-day FDA review.

K173486 · National Taiwan University · Radiology device
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Jul 2018
Decision
240d
Days
Class 2
Risk

K173486 is an FDA 510(k) clearance for the NTU-USB Ultrasound USB Box. 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 National Taiwan University (Taipei, TW). The FDA issued a Cleared decision on July 11, 2018 after a review of 240 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 National Taiwan University devices

Submission Details

510(k) Number K173486 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 2017
Decision Date July 11, 2018
Days to Decision 240 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
133d slower than avg
Panel avg: 107d · This submission: 240d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 786
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K173486.
TE7/TE5 Diagnostic Ultrasound System
K180912 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Jul 2018
EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound System
K181485 · Philips Ultrasound, Inc. · Jul 2018
ARIETTA 65
K181376 · Hitachi Healthcare Americas Corporation · Jul 2018
Transcranial Doppler Ultrasound System
K173801 · Shenzhen Delica Medical Equipment Co., Ltd. · Jul 2018
Vscan Extend
K180995 · GE Medical Systems Ultrasound and Primary Care Diagnostics · Jun 2018
ACUSON SC2000 Diagnostic Ultrasound System
K181098 · Siemens Medical Solutions USA, Inc. · May 2018