System, Imaging, Pulsed Doppler, Ultrasonic
FDA product code IYN · 1075 cleared devices
Class 2
Radiology
- Regulation
- 21 CFR 892.1550
- Review panel
- RA
- Implant
- No
- Life sustaining
- No
- Third party review
- Yes
- GMP exempt
- No
- Clearance span
- 1978-10-10 – 2026-09-25
IYN
2018-11-21
IYN
2018-11-20
Piloter Exp/Piloter/Piloter P Diagnostic Ultrasound System
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IYN
2018-11-15
Voluson E6, Voluson E8, Voluson E10
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IYN
2018-11-14
Z6 Diagnostic Ultrasound System
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IYN
2018-11-09
EPIQ Diagnostic Ultrasound System, EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System, Affiniti 30 Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound System
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IYN
2018-11-06
Vivid T8, Vivid T9
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IYN
2018-11-02
Xario200G and Xario100G, Software V1.1 Diagnostic Ultrasound System
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IYN
2018-11-02
Aplio a550 and a450, Software V2.8 Diagnostic Ultrasound System
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IYN
2018-10-31
Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V3.1
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IYN
2018-10-25
Vivid E80, Vivid E90, Vivid E95
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IYN
2018-10-23
Xperius Ultrasound System
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IYN
2018-10-19
Vivid S60N, Vivid S70N
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IYN
2018-10-11
E-CUBE 8
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IYN
2018-09-28
E-CUBE 12
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IYN
2018-09-20
LOGIQ P9; LOGIQ P7
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IYN
2018-08-27
BenQ Diagnostic Ultrasound System
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IYN
2018-08-17
CBit Series Digital Color Doppler Ultrasound System
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IYN
2018-08-01
Ultrasound Scanner System bk2300
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IYN
2018-07-30
TE7/TE5 Diagnostic Ultrasound System
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IYN
2018-07-27
EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound System
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IYN
2018-07-18
ARIETTA 65
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IYN
2018-07-11
Transcranial Doppler Ultrasound System
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IYN
2018-07-11
NTU-USB Ultrasound USB Box
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IYN
2018-06-25
Vscan Extend
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IYN
2018-05-31
ACUSON SC2000 Diagnostic Ultrasound System
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IYN
2018-05-29
AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach 20, Aixplorer Mach 10
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IYN
2018-05-24
Acclarix LX8 Diagnostic Ultrasound System, Acclarix AX8 Diagnostic Ultrasound System
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IYN
2018-05-22
NeuralBot
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IYN
2018-05-14
Clarius Ultrasound Scanner
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IYN
2018-05-14
Ventripoint Medical System Plus (VMS+)
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IYN
2018-05-11
HS40 Diagnostic Ultrasound System
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IYN
2018-05-09
Navi e/Navi s/Navi X Diagnostic Ultrasound System
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IYN
2018-05-02
Venue
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IYN
2018-04-20
Viamo c100 TUS-VC100 Diagnostic Ultrasound System
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IYN
2018-04-13
SonoSite iViz Ultrasound System
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IYN
2018-04-13
U60 Diagnostic Ultrasound System
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IYN
2018-03-29
Voluson P6 and Voluson P8
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IYN
2018-03-13
Voluson S8/ Voluson S10/ Voluson S10 Expert
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IYN
2018-03-08
HS70A Diagnostic Ultrasound System
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IYN
2018-02-28
ALOKA ARIETTA 850
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IYN
2018-02-23
Ultrasound System 1300
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IYN
2018-02-20
WS80A Diagnostic Ultrasound System
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IYN
2018-02-07
ACUSON X800 Diagnostic Ultrasound System
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IYN
2018-02-05
RS85 Diagnostic Ultrasound System
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IYN
2018-02-02
ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite Diagnostic Ultrasound System
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IYN
2018-02-01
ACUSON P600 Diagnostic Ultrasound System
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IYN
2018-02-01
ACUSON NX3 Diagnostic Ultrasound System; ACUSON NX3 ELITE Diagnostic Ultrasound System
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IYN
2018-01-12
6440 Ultrasound System
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IYN
2018-01-11
Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V2.4
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IYN
2018-01-09
Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic Systems
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IYN
2018-01-08
DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85 Diagnostic
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IYN
2018-01-02
Resona 6/Resona 6T/Resona 6EXP/Resona 6Elite Diagnostic Ultrasound System/Resona 6S/Resona 6PRO/Resona 6OB Diagnostic Ultrasound System /Resona 5/Resona 5T/Resona 5EXP/Resona 5Elite Diagnostic Ultrasound System
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IYN
2018-01-02
Clover 50/Clover60/Clover70 Diagnostic Ultrasound System
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IYN
2017-12-20
LOGIQ E10
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IYN
2017-12-14
E-CUBE 8
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IYN
2017-12-13
DC-30/DC-32/DC-28/DC-26/DC-25 Diagnostic Ultrasound System
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IYN
2017-12-12
Xario 200 Diagnostic Ultrasound System V6.0
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IYN
2017-12-07
Apogee 2100 Digital Color Doppler Ultrasound Imaging System Apogee 2300 Digital Color Doppler Ultrasound Imaging System
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IYN
2017-12-05
P20 Series Digital Color Doppler Ultrasound System
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IYN
2017-12-01
P10 Series Digital Color Doppler Ultrasound System
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IYN
2017-11-15
U50 Diagnostic Ultrasound System
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IYN
2017-11-14
Dolphin/IQ and Dolphin/4D
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IYN
2017-11-07
UltraVision 2 Diagnostic Ultrasound System
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IYN
2017-11-02
Vivid E80, Vivid E90, Vivid E95
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IYN
2017-10-31
ALOKA ARIETTA 850
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IYN
2017-10-27
C5 Diagnostic Ultrasound System
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IYN
2017-10-25
M7/M7T/M7 Premium/M7 Expert/M7 Super Diagnostic Ultrasound
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IYN
2017-10-18
M6/M6T/M6 EXP/M6S/M6 PRO/M5 EXP/M55/M58 Diagnostic Ultrasound System
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IYN
2017-10-12
SONON Ultrasound Imaging System, Model: 300L
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IYN
2017-10-05
LinkQuest Diagnostic Ultrasound System model SQ860
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IYN
2017-10-04
Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System, Affiniti 30 Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound System
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IYN
2017-09-29
U2 Diagnostic Ultrasound System
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IYN
2017-09-29
Voluson E6, Voluson E8, Voluson E10
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IYN
2017-09-21
S60 Series Digital Color Doppler Ultrasound System
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IYN
2017-09-21
ZS3 Ultrasound System, z.one pro Ultrasound System
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IYN
2017-09-14
Clarius Ultrasound System
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IYN
2017-09-12
Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System
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IYN
2017-09-06
Poseidon Ultrasound System
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IYN
2017-08-31
DUS-7000 Digital Color Doppler Ultrasound System
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IYN
2017-08-24
RS80A Diagnostic Ultrasound System
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IYN
2017-08-18
Acclarix AX4 Diagnostic Ultrasound System
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IYN
2017-08-16
ACUSON S3000 S2000 S1000 Diagnostic Ultrasound Systems
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IYN
2017-08-15
ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite Diagnostic Ultrasound System
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IYN
2017-08-10
SmartUs EXT-1M/3M
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IYN
2017-08-09
WS80A Diagnostic Ultrasound System
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IYN
2017-08-08
HS40 Diagnostic Ultrasound System
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IYN
2017-08-03
U-Lite EXP
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IYN
2017-07-12
P50 Series Digital Color Doppler Ultrasound System
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IYN
2017-07-11
AIXPLORER® & AIXPLORER® Ultimate Ultrasound Systems
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IYN
2017-07-11
P60 Series Digital Color Doppler Ultrasound System
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IYN
2017-07-10
M9 Diagnostic Ultrasound System, M9T Diagnostic Ultrasound System, M9CV Diagnostic Ultrasound System, M8 Elite Diagnostic Ultrasound System
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IYN
2017-07-06
Site~Rite Halcyon Diagnostic Ultrasound System
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IYN
2017-06-21
Venue
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IYN
2017-06-14
Vivid S60N, Vivid S70N
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IYN
2017-06-12
SonoSite X-Porte Ultrasound System
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IYN
2017-06-12
Vivid E80, Vivid E90, Vivid E95
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IYN
2017-06-06
SonoBook Series Diagnostic Ultrasound System
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IYN
2017-05-30
TRINITY/3D PROSTATE SUITE
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IYN
2017-05-30
Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.1
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IYN
2017-05-30
ARIETTA PRECISION
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