Handheld Ultrasound Scanner

FDA 510(k) K261288 · Imgfax Co., Ltd.

Substantially Equivalent

510(k) numberK261288

Submission

Device name
Handheld Ultrasound Scanner
Applicant
Imgfax Co., Ltd.
Foshan, CN
Received
April 20, 2026
Decision date
July 30, 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
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
K260667Alturion Series Diagnostic Ultrasound SystemIYN · Traditional Philips Ultrasound, LLC06/29/2026SE

Questions and answers

When was Handheld Ultrasound Scanner cleared by the FDA?

Handheld Ultrasound Scanner (K261288) received a 510(k) decision of Substantially Equivalent on July 30, 2026, 101 days after the submission was received.

What is the product code of K261288?

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