DeviceClearance

LOGIQ Vita +9 more— 510(k) K260673

Substantially Equivalent

GE Medical Systems Ultrasound and Primary Care Diagnostics

FDA 510(k) clearance K260673 for LOGIQ Vita +9 more, Substantially Equivalent on 2026-03-24. Applicant: GE Medical Systems Ultrasound and Primary Care Diagnostics. Device class: 2.

Summary

This GE Medical Systems Ultrasound and Primary Care Diagnostics record lists ten names: LOGIQ Vita, Vita Pro, Vita Express, Vita Plus and Vita Power, and LOGIQ S20, S20 Pro, S20 Express, S20 Plus and S20 Power. All are filed under IYN, pulsed Doppler ultrasonic imaging systems.

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

GE Medical Systems Ultrasound and Primary Care Diagnostics filed from Waukesha, Wisconsin. The decision came 22 calendar days after FDA received it (March 2 to March 24, 2026).

Clearance details

Device name as filed
LOGIQ Vita; LOGIQ Vita Pro; LOGIQ Vita Express; LOGIQ Vita Plus; LOGIQ Vita Power; LOGIQ S20; LOGIQ S20 Pro; LOGIQ S20 Express; LOGIQ S20 Plus; LOGIQ S20 Power
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.