DeviceClearance

Vivid Explorer/Vivid Advanced/Vivid Focus— 510(k) K261313

Substantially Equivalent

GE Medical Systems Ultrasound and Primary Care Diagnostics

FDA 510(k) clearance K261313 for Vivid Explorer/Vivid Advanced/Vivid Focus, Substantially Equivalent on 2026-09-02. Applicant: GE Medical Systems Ultrasound and Primary Care Diagnostics. Device class: 2.

Summary

GE Medical Systems Ultrasound and Primary Care Diagnostics filed Vivid Explorer/Vivid Advanced/Vivid Focus under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic). The record doesn't say how the three named systems differ.

Class II, 21 CFR 892.1550. Radiology is both the classification panel and the review panel. It was a Traditional 510(k), decided Substantially Equivalent.

GE filed from Waukesha, Wisconsin. The decision came 134 calendar days after FDA received it (April 21 to September 2, 2026).

Clearance details

Applicant
GE Medical Systems Ultrasound and Primary Care Diagnostics
Product code
Product code IYN
Device class
Class 2
Regulation
21 CFR 892.1550
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Waukesha, WI, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code IYN

product code IYN
Death
25
Injury
163
Malfunction
1,538
Other
4
Total
1,730

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.