Cleared Abbreviated

K170078 - Medisono Color Doppler Ultrasound System

K170078 is an FDA 510(k) clearance for Medisono Color Doppler Ultrasound System, manufactured by Medisono, LLC. The device is a Class 2 Radiology device with product code IYN cleared through the Abbreviated 510(k) pathway after a 128-day FDA review.

K170078 · Medisono, LLC · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2017
Decision
128d
Days
Class 2
Risk

K170078 is an FDA 510(k) clearance for the Medisono Color Doppler Ultrasound System, models P11 Portable, P11 EXPERT Por.... 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 Medisono, LLC (Wilmington, US). The FDA issued a Cleared decision on May 17, 2017 after a review of 128 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Medisono, LLC devices

FDA 510(k) Submission Details - K170078

510(k) Number K170078 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 09, 2017
Decision Date May 17, 2017
Days to Decision 128 days
Submission Type Abbreviated
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
21d slower than avg
Panel avg: 107d · This submission: 128d
Pathway characteristics
Standards-based clearance path.

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 K170078.
SonoSite X-Porte Ultrasound System
K171437 · FUJIFILM Sonosite, Inc. · Jun 2017
Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.1
K163702 · Toshibamedical Systems Corporation · May 2017
E5 Series Digital Color Doppler Ultrasound System
K170303 · Sonoscape Medical Corp. · 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
Acuson SC2000 Diagnostic Ultrasound System
K170315 · Siemens Medi Cal Solutions, Inc. · Apr 2017