Cleared Traditional

Navi e/Navi s/Navi X Diagnostic Ultrasound System (K180461) - FDA 510(k) Clearance

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

K180461 · Shenzhen Wisonic Medical Technology Co. , Ltd. · Radiology device
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May 2018
Decision
78d
Days
Class 2
Risk

K180461 is an FDA 510(k) clearance for the Navi e/Navi s/Navi X 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 Shenzhen Wisonic Medical Technology Co. , Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on May 9, 2018 after a review of 78 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. 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 Shenzhen Wisonic Medical Technology Co. , Ltd. devices

Submission Details

510(k) Number K180461 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 2018
Decision Date May 09, 2018
Days to Decision 78 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
29d faster than avg
Panel avg: 107d · This submission: 78d
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 631
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K180461.
Ventripoint Medical System Plus (VMS+)
K173810 · Ventripoint Diagnostics , Ltd. · May 2018
Clarius Ultrasound Scanner
K180799 · Clarius Mobile Health Corp. · May 2018
HS40 Diagnostic Ultrasound System
K180409 · Samsung Medison 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
U60 Diagnostic Ultrasound System
K180408 · Edan Instruments, Inc. · Apr 2018