Cleared Traditional

K261313 - Vivid Explorer/Vivid Advanced/Vivid Focus

K261313 is an FDA 510(k) clearance for Vivid Explorer/Vivid Advanced/Vivid Focus, manufactured by GE Medical Systems Ultrasound and Primary Care Diagnostics. The device is a Class 2 Radiology device with product code IYN cleared through the Traditional 510(k) pathway after a 134-day FDA review.

K261313 · GE Medical Systems Ultrasound and Primary Care Diagnostics · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2026
Decision
134d
Days
Class 2
Risk

K261313 is an FDA 510(k) clearance for the Vivid Explorer/Vivid Advanced/Vivid Focus. 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 (Waukesha, US). The FDA issued a Cleared decision on September 2, 2026 after a review of 134 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

FDA 510(k) Submission Details - K261313

510(k) Number K261313 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 2026
Decision Date September 02, 2026
Days to Decision 134 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized Yes - Predetermined Change Control Plan authorized FDA has pre-authorized specific future modifications to this device, a pathway common in AI/SaMD devices.
Regulatory Context
Review time vs. panel average
27d slower than avg
Panel avg: 107d · This submission: 134d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. PCCP authorized - AI/SaMD pathway.

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 1153
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K261313.
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