Cleared Traditional

K173486 - NTU-USB Ultrasound USB Box

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

K173486 · National Taiwan University · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K173486

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.

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 1097
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