Cleared Traditional

K190186 - Acclarix AX4 Diagnostic Ultrasound Syst...

K190186 is the FDA 510(k) clearance for Acclarix AX4 Diagnostic Ultrasound Syst... by Edan Instruments, Inc.. It is a Class 2 Radiology device (product code IYO) cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K190186 · Edan Instruments, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2019
Decision
55d
Days
Class 2
Risk

K190186 is an FDA 510(k) clearance for the Acclarix AX4 Diagnostic Ultrasound System / Acclarix LX4 Diagnostic Ultrasoun.... Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by Edan Instruments, Inc. (Shenzhen, CN). The FDA issued a Cleared decision on March 28, 2019 after a review of 55 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Edan Instruments, Inc. devices

Submission Details

510(k) Number K190186 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 2019
Decision Date March 28, 2019
Days to Decision 55 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
52d faster than avg
Panel avg: 107d · This submission: 55d
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 K190186.
Bladder Scanner (Models: M2, M2-W, M1, M1-W)
K190769 · Suzhou Lischka Medtech Co., Ltd. · May 2019
MD-6000P Bladder Scanner
K182460 · MEDA Co., Ltd. · May 2019
Eye Prime
K190786 · Ellex Medical Pty, Ltd. · Apr 2019
ABSOLU
K183414 · Quantel Medical · Mar 2019
EchoSure Diagnostic Ultrasound System
K190039 · Sonavex, Inc. · Mar 2019
Site~Rite 8 Ultrasound System with Cue Needle Tracking System and Pinpoint GT Needle Tech
K182281 · C. R. Bard · Oct 2018