LOGIQ e

FDA 510(k) K260398 · GE Medical Systems Ultrasound and Primary Care Diagnostics

Substantially Equivalent

510(k) numberK260398

Submission

Device name
LOGIQ e
Applicant
GE Medical Systems Ultrasound and Primary Care Diagnostics
Waukesha, WI, US
Received
February 6, 2026
Decision date
May 26, 2026
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
IYN – System, Imaging, Pulsed Doppler, Ultrasonic
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1550
Specialty
Radiology

Other 510(k)s with product code IYN

510(k)DeviceApplicantDecision
K261313Vivid Explorer/Vivid Advanced/Vivid FocusIYN · Traditional GE Medical Systems Ultrasound and Primary Care…09/02/2026SE
K254027Digital Color Doppler Ultrasound System (Marvo 95/Marvo 95 Elite/Marvo 90/Marvo 90…IYN · Traditional Sonoscape Medical Corp.08/24/2026SE
K261668Venue GoIYN · Traditional GE Medical Systems Ultrasound and Primary care…08/07/2026SE
K262311Alturion Series Diagnostic Ultrasound SystemIYN · Special Philips Ultrasound, LLC08/04/2026SE
K261835LOGIQ FocusIYN · Traditional GE Medical Systems Ultrasound and Primary Care…07/30/2026SE
K261288Handheld Ultrasound ScannerIYN · Traditional Imgfax Co., Ltd.07/30/2026SE
K261412V8/XV8/XH8/H8/cV8/V8 ONE/XV8 ONE/XH8 ONE/H8 ONE/cV8 ONE Diagnostic Ultrasound System…IYN · Traditional Samsung Medison Co., Ltd.07/28/2026SE
K261211Philips EPIQ Series Diagnostic Ultrasound System; Philips Affiniti Series Diagnostic…IYN · Traditional Philips Ultrasound, LLC07/27/2026SE
K261272ePascal S/ ePascal SOR/ ePascal S5/ ePascal SA/ ePascal SE/ ePascal 80Elite/ ePascal 80/…IYN · Traditional Esonic Technology (Wuhan) Co., Ltd.07/23/2026SE
K261081Pocket Ultrasound System (C10MTpro,C10MXpro,C10MSpro,C10MBpro,C10MRpro)IYN · Special Beijing Konted Medical Technology Co.,Ltd07/23/2026SE

More from Beijing Konted Medical Technology Co.,Ltd

510(k)DeviceDecision
K261313Vivid Explorer/Vivid Advanced/Vivid FocusIYN · Traditional 09/02/2026SE
K261668Venue GoIYN · Traditional 08/07/2026SE
K261835LOGIQ FocusIYN · Traditional 07/30/2026SE
K260673LOGIQ Vita; LOGIQ Vita Pro; LOGIQ Vita Express; LOGIQ Vita Plus; LOGIQ Vita Power; LOGIQ…IYN · Traditional 03/24/2026SE
K253370LOGIQ TotusIYN · Traditional 01/08/2026SE
K253366LOGIQ FortisIYN · Traditional 01/07/2026SE
K252328Voluson Expert 18; Voluson Expert 20; Voluson Expert 22IYN · Traditional 11/24/2025SE
K251985Logiq E10IYN · Traditional 10/29/2025SE
K251963LOGIQ E10sIYN · Traditional 10/29/2025SE
K251322Venue; Venue Go; Venue Fit; Venue SprintIYN · Traditional 07/25/2025SE

Questions and answers

When was LOGIQ e cleared by the FDA?

LOGIQ e (K260398) received a 510(k) decision of Substantially Equivalent on May 26, 2026, 109 days after the submission was received.

What is the product code of K260398?

The FDA product code is IYN – System, Imaging, Pulsed Doppler, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1550.