IYN · System, Imaging, Pulsed Doppler, Ultrasonic

Radiology · 21 CFR 892.1550 · Class 2

Overview

Product CodeIYN
Device NameSystem, Imaging, Pulsed Doppler, Ultrasonic
Regulation21 CFR 892.1550
Device ClassClass 2
Review PanelRadiology
3rd-Party ReviewableYes

Identification

An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Classification Rationale

Class II.

Recent Cleared Devices (20 of 1190)

Showing 20 most recent of 1190 cleared devices.

RecordDevice NameApplicantDecision DateDecision
K261585Diagnostic Ultrasound System (Nuewa A20W); Diagnostic Ultrasound System (Nuewa A20); Diagnostic Ultrasound System (Nuewa A20 Exp); Diagnostic Ultrasound System (Nuewa A20 Elite); Diagnostic Ultrasound System (Nuewa A20Q); Diagnostic Ultrasound System (Nuewa A MV); Diagnostic Ultrasound System (Nuewa A Elite); Diagnostic Ultrasound System (Nuewa A MS); Diagnostic Ultrasound System (Nuewa A20 Premium); Diagnostic Ultrasound System (Nuewa A20 Plus); Diagnostic Ultrasound System (Nuewa A18Shenzhen Mindray Bio-Medical Electronics Co., Ltd.Oct 16, 2026SESE
K263150V10 Diagnostic Ultrasound System; cV10 Diagnostic Ultrasound System; H10 Diagnostic Ultrasound System; XV10 Diagnostic Ultrasound System; XH10 Diagnostic Ultrasound System; V10 ONE Diagnostic Ultrasound System; cV10 ONE Diagnostic Ultrasound System; H10 ONE Diagnostic Ultrasound System; XV10 ONE Diagnostic Ultrasound System; XH10 ONE Diagnostic Ultrasound System; HERA Z10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.Oct 8, 2026SESE
K261617Diagnostic Ultrasound System (Resona I10W);Diagnostic Ultrasound System (Resona I10 Exp);Diagnostic Ultrasound System (Resona I10);Diagnostic Ultrasound System (Resona I10S);Diagnostic Ultrasound System (Resona XI);Diagnostic Ultrasound System (Resona I10 CV);Diagnostic Ultrasound System (Nuewa I10W);Diagnostic Ultrasound System (Nuewa I10 Exp);Diagnostic Ultrasound System (Nuewa I10);Diagnostic Ultrasound System (Nuewa I10S);Diagnostic Ultrasound System (Nuewa XI);Diagnostic UltrasounShenzhen Mindray Bio-Medical Electronics Co., Ltd.Oct 8, 2026SESE
K261933Voluson Expert 18; Voluson Expert 20; Voluson Expert 22GE Medical Systems Ultrasound and Primary care Diagnostics, LLCOct 2, 2026SESE
K263182EVO X30 Diagnostic Ultrasound System; EVO X20 Diagnostic Ultrasound System; EVO X10 Diagnostic Ultrasound System; EVO XP30 Diagnostic Ultrasound System; EVO XP20 Diagnostic Ultrasound System; EVO XP10 Diagnostic Ultrasound System; EVO XC30 Diagnostic Ultrasound System; EVO XC20 Diagnostic Ultrasound System; EVO XC10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.Sep 25, 2026SESE
K262548EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLCSep 25, 2026SESE
K261313Vivid Explorer/Vivid Advanced/Vivid FocusGE Medical Systems Ultrasound and Primary Care DiagnosticsSep 2, 2026SESE
K254027Digital Color Doppler Ultrasound System (Marvo 95/Marvo 95 Elite/Marvo 90/Marvo 90 CV/Marvo 90 Pro/Marvo 90 Exp/Marvo 90 Elite/Marvo Expert/Marvo 85/Marvo 85 Pro/Marvo 85 Exp/Marvo 85 Elite/Marvo Senior/Marvo 75 Elite/Marvo 75i/Fenix 95/Fenix 95 Elite/Fenix 90/Fenix 90 Elite/Fenix Expert/Fenix 85/Fenix 85 Elite/Fenix Senior/Fenix 75 Elite/Fenix 75i/Endo 80/Endo 90)Sonoscape Medical Corp.Aug 24, 2026SESE
K261668Venue GoGE Medical Systems Ultrasound and Primary care Diagnostics, LLCAug 7, 2026SESE
K262311Alturion Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLCAug 4, 2026SESE
K261835LOGIQ FocusGE Medical Systems Ultrasound and Primary Care DiagnosticsJul 30, 2026SESE
K261288Handheld Ultrasound ScannerIMGFAX CO., LTD.Jul 30, 2026SESE
K261412V8/XV8/XH8/H8/cV8/V8 ONE/XV8 ONE/XH8 ONE/H8 ONE/cV8 ONE Diagnostic Ultrasound System; V7/XV7/XH7/H7/cV7/V7 ONE/XV7 ONE/H7 ONE/XH7 ONE/cV7 ONE Diagnostic Ultrasound System; V6/XV6/XH6/H6/cV6/V6 ONE/XV6 ONE/H6 ONE/XH6 ONE/cV6 ONE Diagnostic Ultrasound System; V5/XV5/XH5/H5/cV5 Diagnostic Ultrasound System; V4/XV4/XH4/H4/cV4 Diagnostic Ultrasound System;Samsung Medison Co., Ltd.Jul 28, 2026SESE
K261211Philips EPIQ Series Diagnostic Ultrasound System; Philips Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLCJul 27, 2026SESE
K261272ePascal S/ ePascal SOR/ ePascal S5/ ePascal SA/ ePascal SE/ ePascal 80Elite/ ePascal 80/ MOZI-X1/ MOZI-X12/ DF-41E Diagnostic ultrasound systemEsonic Technology (Wuhan) Co., Ltd.Jul 23, 2026SESE
K261081Pocket Ultrasound System (C10MTpro,C10MXpro,C10MSpro,C10MBpro,C10MRpro)Beijing Konted Medical Technology Co.,LtdJul 23, 2026SESE
K260667Alturion Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLCJun 29, 2026SESE
K260844ACUSON Sequoia Diagnostic Ultrasound System;ACUSON Sequoia Select Diagnostic Ultrasound System;ACUSON Origin Diagnostic Ultrasound System;ACUSON Origin ICE Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.Jun 16, 2026SESE
K260748ES-SeriesE-ScopicsJun 9, 2026SESE
K260680EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLCMay 27, 2026SESE

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