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
2022-10-13
IYN
2022-10-11
SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5CB, H5C, 10L, 14L, 10LB, H10L, H5C10L) and SonoFinder Wireless Probe Type Ultrasound Scanner (Model: SF14L25)
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IYN
2022-09-29
Consona N6, Consona N6 Pro, Consona N6 Super, Consona AR, Consona N6S, Consona AE, Consona AT, Consona N6 Exp Diagnostic Ultrasound System, Consona N6 Elite, Consona N6T Diagnostic Ultrasound System
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IYN
2022-09-29
Consona N9, Consona N9 Pro, Consona N9 Super, Consona Nova, Consona N9S, Consona NI, Consona NT, Nuewa N9, Recho N9, Consona N9 Exp, Consona N9 Elite, Resona N9, Consona N9T, Consona N8, Consona N8 Pro, Consona N8 Super, Consona OR, Consona N8S, Consona OI, Consona OT, Consona N8 Exp, Consona N8 Elite, Consona N8T, Consona N7, Consona N7 Pro, Consona N7 Super, Consona VR, Consona N7S, Consona VI, Consona VT, Consona N7 Exp, Consona N7 Elite, Consona N7T Diagnostic Ultrasound System
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IYN
2022-09-27
5000 Compact Series Ultrasound Systems (Ultrasound System 5500 G, Ultrasound System 5500 P, Ultrasound System 5500 W, Ultrasound System 5500 CV, Ultrasound System 5300 G, Ultrasound System 5300 P, Ultrasound System 5300 W)
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IYN
2022-09-15
P12 Elite Series Digital Color Doppler Ultrasound System
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IYN
2022-09-13
P20 Elite Series Digital Color Doppler Ultrasound System
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IYN
2022-09-12
KOLO Evolution XHD Series Ultrasound Diagnostic System
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IYN
2022-08-22
HS40 Diagnostic Ultrasound System
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IYN
2022-08-16
ACUSON Juniper Diagnostic Ultrasound System and ACUSON Juniper Select Diagnostic Ultrasound System
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IYN
2022-07-22
Vivid E80, Vivid E90, Vivid E95
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IYN
2022-07-18
Vivid iq
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IYN
2022-07-18
Vivid T8, Vivid T9
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IYN
2022-07-15
Vivid S60N, Vivid S70N
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IYN
2022-07-08
Transcranial Doppler Ultrasound System
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IYN
2022-06-29
V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound System
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IYN
2022-06-27
Venue
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IYN
2022-06-27
Venue Fit
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IYN
2022-06-23
Ultrasound System SONIMAGE MX1
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IYN
2022-06-21
Venue Go
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IYN
2022-06-17
RS85 Diagnostic Ultrasound System, RS80 EVO Diagnostic Ultrasound System
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IYN
2022-06-14
ACUSON Sequoia Diagnostic Ultrasound System
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IYN
2022-06-08
HD60 Series Ultrasound Diagnostic System
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IYN
2022-06-06
Voluson Expert 22, Voluson Expert 20, Voluson Expert 18
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IYN
2022-05-16
SONON Ultrasound Imaging System, Model: SONON300C
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IYN
2022-05-11
Versana Balance
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IYN
2022-05-06
HM70 EVO Diagnostic Ultrasound System
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IYN
2022-04-29
ARIETTA 50
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IYN
2022-04-22
SONON Ultrasound Imaging System, Model: SONON 500L
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IYN
2022-04-08
ImaCor Zura Handheld ZHH-010
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IYN
2022-04-05
HERA W10 Diagnostic Ultrasound System, HERA W9 Diagnostic Ultrasound System
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IYN
2022-03-25
TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite, TEX10/ TEX10 Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite Diagnostic Ultrasound System
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IYN
2022-03-22
LOGIQ P10, LOGIQ P9, LOGIQ P8
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IYN
2022-03-22
Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Software V6.5
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IYN
2022-03-04
TE Air Diagnostic Ultrasound System
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IYN
2022-03-02
NovaGuide 2 Intelligent Ultrasound
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IYN
2022-02-18
Pocket Ultrasound System
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IYN
2022-02-17
Voluson P6, Voluson P8
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IYN
2022-02-11
ACUSON P500 Ultrasound System
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IYN
2022-02-11
ArtUs
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IYN
2022-01-28
X-CUBE i8, X-CUBE i9
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IYN
2022-01-24
Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V6.5
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IYN
2022-01-13
Voluson S6, Voluson S8, Voluson S8t, Voluson S10, Voluson S10 Expert
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IYN
2022-01-11
ES1 System
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IYN
2021-12-27
Sonosite PX Ultrasound System
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IYN
2021-12-02
Clivia series Diagnostic Ultrasound System
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IYN
2021-11-16
TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite Diagnostic Ultrasound System, TEX10/ TEX10 Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite Diagnostic Ultrasound System
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IYN
2021-11-15
Clarius Ultrasound Scanner
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IYN
2021-11-05
MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX8/MX8T/Vaus8/ME8 Diagnostic Ultrasound System
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IYN
2021-11-03
LELTEK Ultrasound Imaging System (Model: LU700 Series)
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IYN
2021-09-24
Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic Ultrasound System
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IYN
2021-09-16
6430 MyLabX75, 6430 MyLab XPro75
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IYN
2021-09-10
LOGIQ E10
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IYN
2021-09-10
Versana Premier
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IYN
2021-09-09
HERA W9, HERA W10 Diagnostic Ultrasound System
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IYN
2021-09-08
V8 Diagnostic Ultrasound System
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IYN
2021-09-08
EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System
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IYN
2021-08-27
LOGIQ E10s, LOGIQ Fortis
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IYN
2021-08-20
Exo Iris
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IYN
2021-08-19
Apogee 1000/ Apogee 1000Neo/ Apogee 1000Lite/ Apogee 1000Exp/ Apogee 1000B/W / Apogee 1U/ Apogee 1T/ Apogee 1G Digital Color Doppler Ultrasound Imaging System
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IYN
2021-08-18
Apogee 6500,Apogee 6300,Apogee 6200 Digital Color Doppler Ultrasound Imaging System
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IYN
2021-08-09
X-CUBE 90
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IYN
2021-08-09
X-CUBE 70
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IYN
2021-08-06
Kosmos
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IYN
2021-07-30
Labat series Diagnostic Ultrasound System
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IYN
2021-07-20
ACUSON Sequoia Diagnostic Ultrasound System
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IYN
2021-07-09
HM70 EVO Diagnostic Ultrasound System
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IYN
2021-07-01
DC-70/DC-70T/DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System
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IYN
2021-06-29
Aixplorer MACH30/ SUPERSONIC MACH30, Aixplorer MACH20/ SUPERSONIC MACH20, SUPERSONIC MACH40
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IYN
2021-06-25
Apache Ultrasound System
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IYN
2021-06-25
Vu-Path Ultrasound System
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IYN
2021-06-24
RS85 Diagnostic Ultrasound System, RS80 EVO Diagnostic Ultrasound System
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IYN
2021-06-10
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 Diagnostic Ultrasound System
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IYN
2021-06-10
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
2021-06-09
Vivid S60N / Vivid S70N
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IYN
2021-05-13
HS40 Diagnostic Ultrasound System
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IYN
2021-04-09
HS50 Diagnostic Ultrasound System, HS60 Diagnostic Ultrasound System
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IYN
2021-04-08
Resona R9,Resona R9 Exp,Resona R9 Pro,Resona R9S, Nuewa R9,Nuewa R9 Exp,Nuewa R9 Pro,Nuewa R9S,Resona 7,Resona 7CV,Resona 7EXP,Resona 7S, Resona 7OB,Resona 7PRO,Imagyn 7,Resona Y Diagnostic Ultrasound System
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IYN
2021-04-01
ACUSON Redwood Diagnostic Ultrasound System
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IYN
2021-03-23
TE7/TE5/TE7 Max/TE5 Max/TE9 Diagnostic Ultrasound System
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IYN
2021-03-05
Vivid E80/ Vivid E90/ Vivid E95
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IYN
2021-03-02
SonoEye P1/ SonoEye P1-G/ SonoEye V1/ SonoEye V1-G/ SonoEye G1/ SonoEye G1-G Digital Color Doppler Palm Ultrasound System
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IYN
2021-02-26
SonoEye P3/ SonoEye V3/ Sono Eye G3 Digital Color Doppler Palm Ultrasound System
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IYN
2021-02-26
SonoEye P2/ SonoEye V2/ SonoEye G2 Digital Color Doppler Palm Ultrasound System
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IYN
2021-02-25
SonoEye P5/ SonoEye V5/ SonoEye G5 Digital Color Doppler Palm Ultrasound System
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IYN
2021-02-25
SonoEye P6/ SonoEye V6/ SonoEye G6 Digital Color Doppler Palm Ultrasound System
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IYN
2021-02-23
Lumify Diagnostic Ultrasound System
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IYN
2021-01-25
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
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IYN
2021-01-25
Dolphin/IQ, Dolphin/4D and Dolphin/MAX with Dolphin/XF robot accessory
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IYN
2021-01-08
LOGIQ P10, LOGIQ P9, LOGIQ P8
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IYN
2020-12-29
Venue Fit
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IYN
2020-12-29
Aixplorer®MACH20, Aixplorer®MACH30, Supersonic MACH40, Supersonic MACH30 & Supersoinc MACH20 Ultrasonic Diagnostic Systems
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IYN
2020-11-18
Venue Go
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IYN
2020-11-13
Venue
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IYN
2020-11-12
Apache Ultrasound System (Model C62)
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IYN
2020-11-09
EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME2/EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME2 PREMIER PLUS
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IYN
2020-11-09
DC-30/DC-32/DC-28/DC-26/DC-25/DC-20/DC-30 Exp/DC-32 Exp Diagnostic Ultrasound System
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IYN
2020-11-04
Arietta 65
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IYN
2020-10-30
HS30 Diagnostic Ultrasound System
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IYN
2020-10-30
T-Lite
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