Cleared Traditional

Interson USB Ultrasound System (K163443) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K163443 · Interson Corporation · Radiology device
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Apr 2017
Decision
126d
Days
Class 2
Risk

K163443 is an FDA 510(k) clearance for the Interson USB Ultrasound System. 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 Interson Corporation (Pleasanton, US). The FDA issued a Cleared decision on April 13, 2017 after a review of 126 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 Interson Corporation devices

Submission Details

510(k) Number K163443 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 2016
Decision Date April 13, 2017
Days to Decision 126 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
19d slower than avg
Panel avg: 107d · This submission: 126d
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 633
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K163443.
M9 Diagnostic Ultrasound System, M9T Diagnostic Ultrasound System, M9CV Diagnostic Ultrasound System, M8 Elite Diagnostic Ultrasound System
K171034 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Jul 2017
Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.1
K163702 · Toshibamedical Systems Corporation · May 2017
DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System
K163690 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Apr 2017
LOGIQ S8
K170445 · Ge Healthcare · Apr 2017
DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound System
K170277 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Mar 2017
LOGIQ P9 and LOGIQ P7
K163596 · Ge Healthcare · Feb 2017