Cleared Traditional

K181685 - Vivid E80

K181685 is the FDA 510(k) clearance for Vivid E80 by GE Medical Systems Ultrasound and Primary Care Diagnostics. It is a Class 2 Radiology device (product code IYN) cleared through the Traditional 510(k) pathway after a 121-day FDA review.

K181685 · GE Medical Systems Ultrasound and Primary Care Diagnostics · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2018
Decision
121d
Days
Class 2
Risk

K181685 is an FDA 510(k) clearance for the Vivid E80, Vivid E90, Vivid E95. 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 GE Medical Systems Ultrasound and Primary Care Diagnostics (Wauwatosa, US). The FDA issued a Cleared decision on October 25, 2018 after a review of 121 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 GE Medical Systems Ultrasound and Primary Care Diagnostics devices

Submission Details

510(k) Number K181685 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 2018
Decision Date October 25, 2018
Days to Decision 121 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
14d slower than avg
Panel avg: 107d · This submission: 121d
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 K181685.
Aplio a550 and a450, Software V2.8 Diagnostic Ultrasound System
K182427 · Canon Medical Systems Corporation · Nov 2018
Xario200G and Xario100G, Software V1.1 Diagnostic Ultrasound System
K182596 · Canon Medical Systems Corporation · Nov 2018
Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V3.1
K182679 · Canon Medical Systems Corporation · Oct 2018
Xperius Ultrasound System
K182529 · Philips Ultrasound, Inc. · Oct 2018
Vivid S60N, Vivid S70N
K182450 · GE Medical Systems Ultrasound and Primary Care Diagnostics · Oct 2018
E-CUBE 8
K181617 · Alpinion Medical Systems Co., Ltd. · Oct 2018