IYN · Class II · 21 CFR 892.1550

FDA Product Code IYN: System, Imaging, Pulsed Doppler, Ultrasonic

FDA product code IYN covers pulsed Doppler ultrasonic imaging systems.

These devices use pulsed-wave Doppler technology to measure blood flow velocity and visualize vascular structures in real time. They are widely used in cardiology, obstetrics, and vascular diagnostics.

IYN devices are Class II medical devices, regulated under 21 CFR 892.1550 and reviewed by the FDA Radiology panel.

Leading manufacturers include Shenzhen Mindray Bio-Medical Electronics Co., Ltd., Siemens Medical Solutions USA, Inc. and Samsung Medison Co., Ltd..

1185
Total
1185
Cleared
94d
Avg days
1978
Since
1185 devices
289–312 of 1185
Cleared Jan 25, 2021
Diagnostic Ultrasound System, Models: Acclarix AX3, Acclarix AX3 Exp, Acclarix AX3 Super, Acclarix AX25, Acclarix AX28, Acclarix AX2, Acclarix AX2 Exp, Acclarix AX2 Super, Acclarix AX15, Acclarix AX18, Acclarix LX3, Acclarix LX3 Exp, Acclarix LX3 Super, Acclarix LX25 and Acclarix LX28
K202856
Edan Instruments, Inc.
Radiology · 119d
Cleared Jan 08, 2021
LOGIQ P10, LOGIQ P9, LOGIQ P8
K203114
GE Medical Systems Ultrasound and Primary Care Diagnostics
Radiology · 85d
Cleared Dec 29, 2020
Aixplorer®MACH20, Aixplorer®MACH30, Supersonic MACH40, Supersonic MACH30 & Supersoinc MACH20 Ultrasonic Diagnostic Systems
K202455
Supersonic Imagine
Radiology · 124d
Cleared Dec 29, 2020
Venue Fit
K203137
GE Medical Systems Ultrasound and Primary Care Diagnostics
Radiology · 70d
Cleared Nov 18, 2020
Venue Go
K202233
GE Medical Systems Ultrasound and Primary Care Diagnostics
Radiology · 103d
Cleared Nov 13, 2020
Venue
K202132
GE Medical Systems Ultrasound and Primary Care Diagnostics
Radiology · 105d
Cleared Nov 12, 2020
Apache Ultrasound System (Model C62)
K202074
Compal Electronics, Inc.
Radiology · 108d
Cleared Nov 09, 2020
DC-30/DC-32/DC-28/DC-26/DC-25/DC-20/DC-30 Exp/DC-32 Exp Diagnostic Ultrasound System
K201990
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Radiology · 115d
Cleared Nov 09, 2020
EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME2/EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME2 PREMIER PLUS
K203128
Olympus Medical Systems Corp.
Radiology · 21d
Cleared Nov 04, 2020
Arietta 65
K202422
Hitachi Healthcare Americas
Radiology · 72d
Cleared Oct 30, 2020
T-Lite
K201988
Sonoscanner
Radiology · 105d
Cleared Oct 30, 2020
HS30 Diagnostic Ultrasound System
K202556
Samsung Medison Co., Ltd.
Radiology · 57d
Cleared Oct 22, 2020
Voluson E10
K201768
Ge Healthcare
Radiology · 115d
Cleared Oct 16, 2020
Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Xario200G and Xario100G, Diagnostic Ultrasound System
K202737
Canon Medical Systems Corporation
Radiology · 28d
Cleared Oct 15, 2020
Aplio a550, Aplio a450, Aplio a, Diagnostic Ultrasound System, Software V5.1
K202364
Canon Medical Systems Corporation
Radiology · 57d
Cleared Oct 15, 2020
ACUSON Sequoia Diagnostic Ultrasound System, ACUSON SC2000 Diagnostic Ultrasound System, ACUSON Freestyle Diagnostic Ultrasound System,ACUSON S1000, S2000, S3000 Diagnostic Ultrasound Systems, ACUSON P200 Diagnostic Ultrasound System, ACUSON P500 Diagnostic Ultrasound System, ACUSON NX3, NX3 Elite Diagnostic Ultrasound System
K202683
Siemens Medical Solutions USA, Inc.
Radiology · 30d
Cleared Oct 11, 2020
Voluson SWIFT, Voluson SWIFT+
K201828
GE Medical Systems Ultrasound and Primary Care Diagnostics
Radiology · 101d
Cleared Oct 08, 2020
Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V5.1
K201972
Canon Medical Systems Corporation
Radiology · 85d
Cleared Sep 16, 2020
Butterfly iQ Ultrasound System
K202406
Butterfly Network, Inc.
Radiology · 26d
Cleared Sep 09, 2020
Vivid iq
K200708
Ge Medical Systems Ultrasound And
Radiology · 175d
Cleared Sep 09, 2020
Vivid T8, Vivid T9
K200851
GE Medical Systems Ultrasound and Primary Care Diagnostics
Radiology · 162d
Cleared Sep 02, 2020
EPIQ Series Diagnostic Ultrasound Systems
K202216
Philips Ultrasound, Inc.
Radiology · 27d
Cleared Sep 01, 2020
Sonosite PX Ultrasound System, Sonosite SII Ultrasound System, Sonosite iViz Ultrasound System, Sonosite X-Porte Ultrasound System, Sonosite Edge II Ultrasound System, Sonosite Maxx Ultrasound System
K202160
FUJIFILM Sonosite, Inc.
Radiology · 29d
Cleared Aug 21, 2020
DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80AExp/DC-80A Pro/DC-8X/DC-8Q/DC-81/DC-82 Diagnostic Ultrasound System
K201693
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Radiology · 60d