Cleared Special

K180408 - U60 Diagnostic Ultrasound System

K180408 is the FDA 510(k) clearance for U60 Diagnostic Ultrasound System by Edan Instruments, Inc.. It is a Class 2 Radiology device (product code IYN) cleared through the Special 510(k) pathway after a 58-day FDA review.

K180408 · Edan Instruments, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2018
Decision
58d
Days
Class 2
Risk

K180408 is an FDA 510(k) clearance for the U60 Diagnostic 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 Edan Instruments, Inc. (Shenzhen, CN). The FDA issued a Cleared decision on April 13, 2018 after a review of 58 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1550 - the FDA radiology and imaging software oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Edan Instruments, Inc. devices

Submission Details

510(k) Number K180408 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 2018
Decision Date April 13, 2018
Days to Decision 58 days
Submission Type Special
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
49d faster than avg
Panel avg: 107d · This submission: 58d
Pathway characteristics
Modification to existing cleared device.

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 Consultant

Edan Medical
Doug Worth

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - IYN System, Imaging, Pulsed Doppler, Ultrasonic

All 785
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K180408.
Navi e/Navi s/Navi X Diagnostic Ultrasound System
K180461 · Shenzhen Wisonic Medical Technology Co. , Ltd. · May 2018
Venue
K180599 · GE Medical Systems Ultrasound and Primary Care Diagnostics · May 2018
Viamo c100 TUS-VC100 Diagnostic Ultrasound System
K173962 · Toshibamedical Systems Corporation · Apr 2018
SonoSite iViz Ultrasound System
K180704 · FUJIFILM Sonosite, Inc. · Apr 2018
Voluson P6 and Voluson P8
K180535 · Ge Healthcare · Mar 2018
Voluson S8/ Voluson S10/ Voluson S10 Expert
K180374 · Ge Healthcare · Mar 2018