Pocket Ultrasound System (C10MTpro,C10MXpro,C10MSpro,C10MBpro,C10MRpro)

FDA 510(k) K261081 · Beijing Konted Medical Technology Co.,Ltd

Substantially Equivalent

510(k) numberK261081

Submission

Device name
Pocket Ultrasound System (C10MTpro,C10MXpro,C10MSpro,C10MBpro,C10MRpro)
Applicant
Beijing Konted Medical Technology Co.,Ltd
Beijing, CN
Received
April 1, 2026
Decision date
July 23, 2026
Decision
Substantially Equivalent (SESE)
Type
Special 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
K260667Alturion Series Diagnostic Ultrasound SystemIYN · Traditional Philips Ultrasound, LLC06/29/2026SE

More from Philips Ultrasound, LLC

510(k)DeviceDecision
K241979Pocket Ultrasound System (C10, C10TX, C10RL, C10RLpro)IYN · Special 08/22/2024SE
K231354Pocket Ultrasound System (C10)IYN · Traditional 12/20/2023SE

Questions and answers

When was Pocket Ultrasound System (C10MTpro,C10MXpro,C10MSpro,C10MBpro,C10MRpro) cleared by the FDA?

Pocket Ultrasound System (C10MTpro,C10MXpro,C10MSpro,C10MBpro,C10MRpro) (K261081) received a 510(k) decision of Substantially Equivalent on July 23, 2026, 113 days after the submission was received.

What is the product code of K261081?

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