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
2020-10-22
IYN
2020-10-16
Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Xario200G and Xario100G, Diagnostic Ultrasound System
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IYN
2020-10-15
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
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IYN
2020-10-15
Aplio a550, Aplio a450, Aplio a, Diagnostic Ultrasound System, Software V5.1
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IYN
2020-10-11
Voluson SWIFT, Voluson SWIFT+
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IYN
2020-10-08
Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V5.1
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IYN
2020-09-16
Butterfly iQ Ultrasound System
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IYN
2020-09-09
Vivid T8, Vivid T9
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IYN
2020-09-09
Vivid iq
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IYN
2020-09-02
EPIQ Series Diagnostic Ultrasound Systems
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IYN
2020-09-01
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
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IYN
2020-08-21
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
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IYN
2020-08-05
XBit Series Digital Color Doppler Ultrasound System
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IYN
2020-07-30
S60 Elite Series/S70 Series Digital Color Doppler Ultrasound System
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IYN
2020-07-24
Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus 7T/Hepatus 6T/Hepatus 5T/Fibrous 7/Fibrous
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IYN
2020-07-23
Vivid E80/ Vivid E90/ Vivid E95
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IYN
2020-07-16
Vivid S60N, Vivid S70N
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IYN
2020-07-10
X-Cube 70
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IYN
2020-07-10
X-Cube 90
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IYN
2020-07-02
Terason uSmart 3200T Plus Ultrasound System
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IYN
2020-07-01
Versana Premier
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IYN
2020-06-24
ACUSON Sequoia Diagnostic Ultrasound System
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IYN
2020-06-11
Versana Active
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IYN
2020-05-28
DP-50/DP-50T/DP-50Expert/DP-50S/DP-50Pro Digital Ultrasonic Diagnostic Imaging System
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IYN
2020-05-26
ACUSON Juniper Diagnostic Ultrasound System
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IYN
2020-05-21
Acclarix AX8 Diagnostic Ultrasound System / Acclarix LX9 Series Diagnostic Ultrasound System
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IYN
2020-05-08
Sonosite PX Ultrasound System
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IYN
2020-05-07
HS70A Diagnostic Ultrasound System
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IYN
2020-05-01
EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series, CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System, Lumify Diagnostic Ultrasound System
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IYN
2020-04-22
Acuson SC2000 Diagnostic Ultrasound System
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IYN
2020-04-17
LOGIQ E10
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IYN
2020-04-15
ACUSON Sequoia Diagnostic Ultrasound System
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IYN
2020-04-10
ACUSON Freestyle Diagnostic Ultrasound System
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IYN
2020-04-09
MX7/ MX7T/ Vaus7/ Zeus Diagnostic Ultrasound System, ME7/ Anesus ME7/ Anesus ME7T Diagnostic Ultrasound System, MX8/ MX8T/ Vaus8/ ME8 Diagnostic Ultrasound System
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IYN
2020-04-08
Z6/Z60/Z60T/Z60S/Z60 Pro/DP-60 Diagnostic Ultrasound System
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IYN
2020-04-07
HS40 Diagnostic Ultrasound System
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IYN
2020-04-02
Z5/Z50/Z50T/Z50S/Z50 Pro Diagnostic Ultrasound System
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IYN
2020-04-01
LOGIQ E10s
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IYN
2020-03-26
KOSMOS
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IYN
2020-03-12
SonoVision Ultrasound Imaging System
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IYN
2020-03-06
EPIQ Diagnostic Ultrasound System
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IYN
2020-02-12
Leltek Ultrasound Imaging System
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IYN
2020-02-07
Paragon XHD Diagnostic Ultrasound System
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IYN
2020-01-31
ACUSON Sequoia Diagnostic Ultrasound System
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IYN
2020-01-28
Terason uSmart3200T Ultrasound System
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IYN
2020-01-23
VINNO 8, VINNO 6, VINNO 5
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IYN
2020-01-06
RS85 Diagnostic Ultrasound System
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IYN
2019-12-19
ZS3 and z.one pro Ultrasound Systems
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IYN
2019-12-13
DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85/DC-86/DC-86S/DC-89/DC-TV/DC-TQ Diagnostic Ultrasound System
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IYN
2019-12-12
HS50/HS60 Diagnostics Ultrasound System
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IYN
2019-12-10
HERA W9 Diagnostic Ultrasound System, HERA W10 Diagnostic Ultrasound System
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IYN
2019-11-22
6450 Ultrasound system
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IYN
2019-10-25
Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic Systems
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IYN
2019-10-22
ACUSON NX3 Diagnostic Ultrasound System / ACUSON NX3 Elite Diagnostic Ultrasound System
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IYN
2019-10-01
ExactVu High Resolution Micro-Ultrasound System
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IYN
2019-09-19
RS80 EVO Diagnostic Ultrasound System
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IYN
2019-09-18
InnoSight Diagnostic Ultrasound System
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IYN
2019-09-18
Aplio a550, Aplio a450 and Aplio a, Diagnostic Ultrasound System, V4.0
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IYN
2019-09-06
Lumify Diagnostic Ultrasound System
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IYN
2019-08-29
Voluson E6, Voluson E8, Voluson E10
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IYN
2019-08-29
Clarius Ultrasound Scanner
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IYN
2019-08-15
ACUSON P200 Diagnostic Ultrasound System
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IYN
2019-08-09
Versana Active
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IYN
2019-08-09
Versana Balance
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IYN
2019-08-09
ARIETTA 750
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IYN
2019-07-19
Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V4.0
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IYN
2019-07-10
Full Digital Colour Doppler Ultrasonic Diagnostic System
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IYN
2019-06-13
Transcranial Doppler Ultrasound System
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IYN
2019-06-12
RS85 Diagnostic Ultrasound System
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IYN
2019-06-12
HS40 Diagnostic Ultrasound System
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IYN
2019-06-10
7410 Ultrasound System (MyLabSigma)
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IYN
2019-05-22
HERA I10 Diagnostic Ultrasound System
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IYN
2019-05-16
Dolphin/IQ, Dolphin/4D and Dolphin/MAX
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IYN
2019-05-10
ExactVu High Resolution Micro-Ultrasound System
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IYN
2019-05-10
6400 Ultrasound System (MyLabX6, MyLabX7)
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IYN
2019-04-09
DP-10/DP-20/DP-30 Digital Ultrasonic Diagnostic Imaging System
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IYN
2019-04-05
TCD-X
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IYN
2019-04-04
DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound System
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IYN
2019-04-02
ARIETTA 50
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IYN
2019-04-01
7400 Ultrasound Systems
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IYN
2019-03-20
ACUSON S3000, S2000 Diagnostic Ultrasound System
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IYN
2019-03-15
FUJIFILM Sonosite Vevo MD Imaging System
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IYN
2019-03-08
DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80A Exp/DC-80A Pro/DC-8X/DC-8Q/DC-81/DC-82 Diagnostic Ultrasound System
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IYN
2019-03-05
Imagio Ultrasound Imaging System
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IYN
2019-02-15
RS85 Diagnostic Ultrasound System
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IYN
2019-02-07
SonoSite SII Ultrasound System
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IYN
2019-01-29
X5 Series Digital Color Doppler Ultrasound System
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IYN
2019-01-28
Aloka Arietta 850
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IYN
2019-01-28
Venue GO
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IYN
2019-01-24
E-CUBE i7
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IYN
2019-01-22
HM70A Diagnostic Ultrasound System
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IYN
2019-01-10
DC-60/DC-60S/DC-60 Exp/DC-55 Diagnostic Ultrasound System
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IYN
2019-01-09
DC-70/DC-70T/DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System
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IYN
2019-01-08
HS30 Diagnostic Ultrasound System
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IYN
2018-12-27
minisono
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IYN
2018-12-20
Color Doppler Ultrasound System; Model: mEye1 and mEye2
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IYN
2018-12-18
HERA W10 Diagnostic Ultrasound System
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IYN
2018-12-06
Vivid iq
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IYN
2018-12-04
6420 Ultrasound System
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IYN
2018-12-04
HS50 / HS60 Diagnostic Ultrasound System
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