Cleared Traditional

K202856 - Diagnostic Ultrasound System

K202856 is the FDA 510(k) clearance for Diagnostic Ultrasound System by Edan Instruments, Inc.. It is a Class 2 Radiology device (product code IYN) cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K202856 · Edan Instruments, Inc. · Radiology device
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Jan 2021
Decision
119d
Days
Class 2
Risk

K202856 is an FDA 510(k) clearance for the Diagnostic Ultrasound System, Models: Acclarix AX3, Acclarix AX3 Exp, Acclari.... 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 Edan Instruments, Inc. (Shenzhen, CN). The FDA issued a Cleared decision on January 25, 2021 after a review of 119 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 Edan Instruments, Inc. devices

Submission Details

510(k) Number K202856 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2020
Decision Date January 25, 2021
Days to Decision 119 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
12d slower than avg
Panel avg: 107d · This submission: 119d
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 K202856.
SonoEye P5/ SonoEye V5/ SonoEye G5 Digital Color Doppler Palm Ultrasound System
K201971 · CHISON Medical Technologies Co., Ltd. · Feb 2021
Lumify Diagnostic Ultrasound System
K203406 · Philips Ultrasound, Inc. · Feb 2021
Dolphin/IQ, Dolphin/4D and Dolphin/MAX with Dolphin/XF robot accessory
K202742 · Viasonix , Ltd. · Jan 2021
LOGIQ P10, LOGIQ P9, LOGIQ P8
K203114 · GE Medical Systems Ultrasound and Primary Care Diagnostics · Jan 2021
Aixplorer®MACH20, Aixplorer®MACH30, Supersonic MACH40, Supersonic MACH30 & Supersoinc MACH20 Ultrasonic Diagnostic Systems
K202455 · Supersonic Imagine · Dec 2020
Venue Fit
K203137 · GE Medical Systems Ultrasound and Primary Care Diagnostics · Dec 2020