Cleared Traditional

K200743 - Vivid E80/ Vivid E90/ Vivid E95

K200743 is an FDA 510(k) clearance for Vivid E80/ Vivid E90/ Vivid E95, manufactured by Ge Medical Systems Ultrasound And. The device is a Class 2 Radiology device with product code IYN cleared through the Traditional 510(k) pathway after a 122-day FDA review.

K200743 · Ge Medical Systems Ultrasound And · Radiology device
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Jul 2020
Decision
122d
Days
Class 2
Risk

K200743 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 (Wauwatosa, US). The FDA issued a Cleared decision on July 23, 2020 after a review of 122 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 devices

FDA 510(k) Submission Details - K200743

510(k) Number K200743 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 2020
Decision Date July 23, 2020
Days to Decision 122 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
15d slower than avg
Panel avg: 107d · This submission: 122d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IYN Device Classification - Class 2, Special Controls

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 873
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K200743.
XBit Series Digital Color Doppler Ultrasound System
K200780 · CHISON Medical Technologies Co., Ltd. · Aug 2020
S60 Elite Series/S70 Series Digital Color Doppler Ultrasound System
K201059 · Sonoscape Medical Corp. · Jul 2020
Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus 7T/Hepatus 6T/Hepatus 5T/Fibrous 7/Fibrous
K200643 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Jul 2020
Vivid S60N, Vivid S70N
K200497 · GE Medical Systems Ultrasound and Primary Care Diagnostics · Jul 2020
X-Cube 90
K200449 · Alpinion Medical Systems Co., Ltd. · Jul 2020
X-Cube 70
K200450 · Alpinion Medical Systems Co., Ltd. · Jul 2020