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
2024-12-10
IYN
2024-12-10
V5 Diagnostic Ultrasound System, H5 Diagnostic Ultrasound System, XV5 Diagnostic Ultrasound System, XH5 Diagnostic Ultrasound System, V4 Diagnostic Ultrasound System, H4 Diagnostic Ultrasound System, XV4 Diagnostic Ultrasound System, XH4 Diagnostic Ultrasound System
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IYN
2024-11-27
HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound System
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IYN
2024-11-19
ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound System; ACUSON Origin Diagnostic Ultrasound System; ACUSON Origin ICE Diagnostic Ultrasound System
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IYN
2024-11-15
ACUSON Redwood Diagnostic Ultrasound System
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IYN
2024-11-15
The 5000 Compact Series Ultrasound Systems
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IYN
2024-11-08
Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona A20 Exp, Resona A20 Premium, Resona A20 Elite, Resona A20 Plus, Resona A Elite, Resona A MV, Eagus A20W, Eagus A20 Diagnostic Ultrasound System
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IYN
2024-10-24
Portable Digital Color Doppler Ultrasound System (SCN201D, SCN201L)
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IYN
2024-10-11
HERA Z20, R20, HERA Z30, R30 Diagnostic Ultrasound System
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IYN
2024-10-07
EPIQ Series Diagnostic Ultrasound System
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IYN
2024-10-02
Versana Premier; Versana Premier Lotus; LOGIQ F
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IYN
2024-09-20
SuperSonic HepaVu
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IYN
2024-09-18
EdgeLife Handheld Wireless Ultrasound System (E8200); EdgeLife Handheld Wireless Ultrasound System (E8220)
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IYN
2024-09-16
TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite/TEX10/TEX10 Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite/Anesus TEX20 Pro/Eagus TEX20/Eagus TEX20T/Eagus TEX21/Eagus TEX21T/Eros/TE X Plus/Anesus TEX10 Pro/TEX9U/TEX9M/Eagus TEX11/Eagus TEX11T/EagusTEX10/Eagus TEX10T/Eagus TEX/Ares Diagnostic Ultrasound System
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IYN
2024-09-12
Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0 (TUS-AI900, TUS-AI800, TUS-AI700)
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IYN
2024-09-12
MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX7P/MX7W/MX8/MX8T/Vaus8/ME8 Diagnostic Ultrasound System
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IYN
2024-09-11
FETOLY-HEART
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IYN
2024-09-11
Ultrasound Imaging System (LK128L); Ultrasound Imaging System (LK128LH); Ultrasound Imaging System (LK128C); Ultrasound Imaging System (LK128M); Ultrasound Imaging System (LK128PA); Ultrasound Imaging System (LK128E); Ultrasound Imaging System (LU700C); Ultrasound Imaging System (LU700L); Ultrasound Imaging System (LU710L); Ultrasound Imaging System (LU710LH); Ultrasound Imaging System (LU710C); Ultrasound Imaging System (LU710M); Ultrasound Imaging System (LU710PA); Ultrasound Imaging
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IYN
2024-08-30
Vave Wireless Ultrasound System
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IYN
2024-08-29
Kosmos
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IYN
2024-08-22
Pocket Ultrasound System (C10, C10TX, C10RL, C10RLpro)
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IYN
2024-08-09
SonoMax Series Digital Color Doppler Ultrasound System
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IYN
2024-07-23
TE Air Diagnostic Ultrasound System
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IYN
2024-07-22
ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound System, ACUSON Origin Diagnostic Ultrasound System, ACUSON Origin ICE Diagnostic Ultrasound System
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IYN
2024-06-21
V8/XV8/XH8, V7/XV7/XH7, V6/XV6/XH6 Diagnostic Ultrasound System
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IYN
2024-06-17
Resona I9, Resona I9 Exp, Resona I9S, Resona I9T, Resona I9 Easi, Resona I9 Nasa, Resona IV, Imagyn I9, Imagyn I9S, Imagyn I9 Easi, Nuewa I9, Nuewa I9S, Nuewa I9T, Nuewa I9 Exp, Nuewa I9 Easi, Anesus I9, Anesus I9 Easi, Eagus I9, Resona I9W, Recho I9, Recho I9 Pro, Recho I9 Exp, Recho I9S, Recho I9T Diagnostic Ultrasound System
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IYN
2024-06-14
Clarius OB AI
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IYN
2024-06-12
RS85 Diagnostic Ultrasound System
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IYN
2024-06-12
ACUSON P500 Ultrasound System; ACUSON P500 ICE Ultrasound System
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IYN
2024-06-10
Venue Sprint
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IYN
2024-06-10
Venue
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IYN
2024-06-10
Venue Go
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IYN
2024-06-10
Venue Fit
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IYN
2024-05-16
HD80 Series Ultrasound Diagnostic System
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IYN
2024-05-02
Color Doppler Ultrasound Diagnostic System (CMS1700B), Color Doppler Ultrasound Diagnostic System (CMS1700C)
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IYN
2024-04-26
Sonio Detect
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IYN
2024-04-24
EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems
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IYN
2024-04-22
Resona I8W, Resona I8, Resona I8 Exp, Resona I8S, Resona I8T, Resona IY,Resona I8 Easi, Eagus I8 Easi, Nuewa I8W, Nuewa I8, Nuewa I8 Exp, NuewaI8S, Nuewa I8T, Imagyn I8, Imagyn I8S, Imagyn I8T, Imagyn I8 Exp, Nuewa IY Diagnostic Ultrasound System
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IYN
2024-03-22
Digital Ultrasonic Diagnostic Imaging System (Model: F6)
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IYN
2024-03-07
Voluson Signature 20, Voluson Signature 18
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IYN
2024-02-21
HD60 Series Ultrasound Diagnostic System
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IYN
2024-02-15
MS55 Plus Digital Color Doppler Ultrasound System (MS55); P25 Expert Digital Color Doppler Ultrasound System (P25 Expert); P12 Plus Digital Color Doppler Ultrasound System (P12 Plus); P11 Plus Portable Digital Color Doppler Ultrasound System (P11 Plus); P9 Plus Ultrasound Diagnostic System (P9 Plus); P3 Plus Ultrasound Diagnostic System (P3 Plus)
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IYN
2024-02-13
EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System
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IYN
2024-01-28
Gem Flow Now (GEM2770-FN)
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IYN
2024-01-24
Aplio i900, Aplio i800 and Aplio i700 Software V8.1 Diagnostic Ultrasound System
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IYN
2024-01-11
U-Lite PRO
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IYN
2024-01-04
Butterfly iQ3 Ultrasound System
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IYN
2023-12-22
Interson USB Ultrasound System
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IYN
2023-12-21
HM70 EVO Diagnostic Ultrasound System
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IYN
2023-12-20
Pocket Ultrasound System (C10)
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IYN
2023-12-07
LOGIQ Totus
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IYN
2023-12-06
Sonosite LX Ultrasound System
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IYN
2023-11-30
EPIQ Series Diagnostic Ultrasound System
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IYN
2023-11-29
6440 MyLabX90
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IYN
2023-11-21
Aplio flex and Aplio go Software V2.0 Diagnostic Ultrasound System
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IYN
2023-11-20
ARIETTA x10
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IYN
2023-11-07
LOGIQ E10s, LOGIQ Fortis
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IYN
2023-11-07
LOGIQ E10
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IYN
2023-11-03
LOGIQ e
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IYN
2023-10-30
ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound System, ACUSON Origin Diagnostic Ultrasound System
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IYN
2023-10-30
Voluson Expert 22, Voluson Expert 20, Voluson Expert 18
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IYN
2023-10-26
Lumify Diagnostic Ultrasound System
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IYN
2023-10-26
TE Air Diagnostic Ultrasound System
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IYN
2023-10-24
Aco Apache Ultrasound System
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IYN
2023-10-23
Ultrasound System 1300
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IYN
2023-10-05
Clarius Ultrasound Scanner
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IYN
2023-10-03
V8/H8 Diagnostic Ultrasound System, V7/H7 Diagnostic Ultrasound System, V6/H6 Diagnostic Ultrasound System
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IYN
2023-09-26
ACUSON Maple Diagnostic Ultrasound System, ACUSON Maple Select Diagnostic Ultrasound System
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IYN
2023-09-26
ES Series V2
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IYN
2023-09-15
Carnation series Diagnostic Ultrasound System
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IYN
2023-08-15
Vscan Air
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IYN
2023-07-25
Sonio Detect
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IYN
2023-06-23
VINNO G86,VINNO G86E,VINNO G65,VINNO G65P,VINNO G65E,VINNO G65D,VINNO M86, VINNO M86E,VINNO G90,VINNO G90E
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IYN
2023-06-20
Voluson SWIFT; Voluson SWIFT+
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IYN
2023-06-17
VINNO G50, VINNO G55, VINNO M50, VINNO E30, VINNO X5, VINNO X6, VINNO X7, VINNO M55, VINNO E35, VINNO X65, VINNO X55, VINNO X35, VINNO G55E, VINNO G55P, VINNO M55E, VINNO M55P, VINNO E35E, VINNO E35P
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IYN
2023-06-17
VINNO E20, VINNO E10,VINNO E10P,VINNO E10E, VINNO X1,VINNO X1E,VINNO X1P, VINNO X2,VINNO X2E,VINNO X2P
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IYN
2023-06-09
M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium Diagnostic Ultrasound System
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IYN
2023-05-12
EPIQ Series Diagnostic Ultrasound System
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IYN
2023-05-04
Lumify Diagnostic Ultrasound System
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IYN
2023-04-21
HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound System
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IYN
2023-04-17
X-CUBE 50, X-CUBE 60
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IYN
2023-04-11
Ultrasound System 2300
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IYN
2023-03-31
SonoAir Series Digital Color Doppler Ultrasound System
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IYN
2023-03-31
Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0
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IYN
2023-02-16
Vivid S60N, Vivid S70N
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IYN
2023-02-15
Versana Essential
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IYN
2023-02-13
ACUSON Juniper Diagnostic Ultrasound System, ACUSON Juniper Select Diagnostic Ultrasound System
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IYN
2023-02-13
V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound System
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IYN
2023-02-10
S90 Exp Series Digital Color Doppler Ultrasound System
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IYN
2023-02-07
Resona R9/ Resona R9 Exp/ Resona R9 Pro/ Resona R9S/ Nuewa R9/ Nuewa R9 Exp Diagnostic Ultrasound Sysem, Nuewa R9 Pro/ Nuewa R9S/ Resona 7/ Resona 7CV/Resona 7EXP/Resona 7S/ Resona 70B Diagnostic Ultrasound System, Resona 7PRO/Imagyn 7/ Resona Y/Resona R9W/Resona R7W Nuewa R9W/Nuewa R7W Diagnostic Ultrasound System
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IYN
2023-02-06
ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound System
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IYN
2022-12-21
VINNO 6PRO, VINNO 6EXP, VINNO 5PRO, VINNO 5EXP, VINNO 3, VINNO 3PRO, VINNO 3EXP
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IYN
2022-12-07
Ultrasound System 2300
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IYN
2022-11-11
ImSonic TR-1 Ultrasonic Pulsed Doppler Imaging System
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IYN
2022-11-09
ViewMate Multi Ultrasound System
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IYN
2022-11-09
Exo Iris (El2001)
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IYN
2022-10-28
Aixplorer MACH30 / SUPERSONIC MACH30, Aixplorer MACH20 / SUPERSONIC , MACH20, SUPERSONIC MACH40
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IYN
2022-10-25
Leltek Ultrasound Imaging System (Model: LU700 Series)
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IYN
2022-10-14
X-CUBE 70, X-CUBE 90
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IYN
2022-10-13
X-CUBE 50, X-CUBE 60
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