Transducer, Ultrasonic, Diagnostic
FDA product code ITX · 410 cleared devices
Class 2
Radiology
- Regulation
- 21 CFR 892.1570
- Review panel
- RA
- Implant
- No
- Life sustaining
- No
- Third party review
- Yes
- GMP exempt
- No
- Clearance span
- 1978-05-09 – 2026-09-24
ITX
2026-09-24
ITX
2026-08-12
BA-004CC
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ITX
2026-08-10
EM-TECH Passive Ultrasound Probe Strap
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ITX
2026-07-30
SmartGuide Disposable Guides and Grids
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ITX
2026-07-27
ND Needle Guidance System
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ITX
2026-07-24
Accuro® 3S Needle Guide Kit
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ITX
2025-09-18
ULTRASONIC PROBE UM-3R (UM-3R); ULTRASONIC PROBE UM-G20-29R (UM-G20-29R)
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ITX
2025-07-11
ULTRASONIC PROBE UM-S20-17S (UM-S20-17S); ULTRASONIC PROBE UM-S20-20R (UM-S20-20R)
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ITX
2025-07-02
Mendaera Guidance System
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ITX
2025-06-13
Accuro® 3S Needle Guide Kit
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ITX
2024-08-30
Ultrasound Transducer Cover
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ITX
2024-08-15
UltraDrape UGPIV Barrier and Securement (34-15)
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ITX
2024-07-03
Transducer Probe Cover
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ITX
2023-12-22
TP Pivot Pro™ Needle Guide
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ITX
2023-12-13
Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L)
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ITX
2023-11-14
VitroPRO
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ITX
2023-08-02
Disposable Needle Guides and Grids
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ITX
2023-05-12
Intraoperative Ultrasound Probe Cover
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ITX
2023-01-11
Transducer Probe Cover
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ITX
2022-11-22
VitroPRO
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ITX
2022-06-07
Natural Rubber Latex Ultrasound Transducer Probe Covers
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ITX
2021-09-13
CIV-Clear cover
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ITX
2021-08-13
EMM Ultrasonic Transducer Cover
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ITX
2021-02-19
Disposable Intraoperative Probe (DIOP8)
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ITX
2020-11-20
Vscan Air
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ITX
2020-06-05
EZ-Cover
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ITX
2020-04-17
Opticross 35 15 MHz Peripheral Imaging Catheter
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ITX
2019-05-24
Envision ultrasound pad and cover
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ITX
2018-07-17
Cook-Swartz Doppler Flow Probe
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ITX
2018-07-10
Disposable guides KDNG00
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ITX
2017-07-31
Reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) and STEADY PRO range
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ITX
2017-06-09
ASTRA TEE Transesophageal Probe Reprocessor, ASTRA VR Endovaginal/Endorectal Probe Reprocessor
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ITX
2017-06-01
GTK Disposable Needle Guides
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ITX
2017-05-22
Pinpoint GT Needle Guide Kits
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ITX
2017-05-16
A-View
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ITX
2017-05-16
iSR'obot Biopsy Kit
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ITX
2016-08-17
UST-5550-R; UST-5536-R; L43K
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ITX
2016-08-05
Verza Guidance System
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ITX
2016-08-01
Precision Point Biopsy Needle Guide
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ITX
2016-03-04
Sheathes Ultrasound Probe Covers
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ITX
2013-09-17
EX3 STEPPER, CLASSIC STEPPER, MULTI-PURPOSE WORKSTATION STEPPER; MICRO-TOUCH, MICRO-TOUCH LP, MULIT-PURPOSE WORKSTATION,
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ITX
2013-06-11
NON-PYROGENIC ULTRASOUND TRANSDUCER COVER
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ITX
2013-02-20
MDU5 PLUS STERILE BAG
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ITX
2012-10-05
C1-6-D ULTRASOUND TRANSDUCER
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ITX
2012-09-11
C2-9-D ULTRASOUND TRANSDUCER
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ITX
2012-08-17
VIVID I DIAGNOSTIC ULTRASOUND SYSTEM, VIVID Q DIAGNOSTIC ULTRASOUND SYSTEM
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ITX
2012-07-10
V5MS TRANSDUCER
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ITX
2012-03-06
SONICEYE ULTRASOUND TRANSDUCER
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ITX
2012-03-01
EUCLID (TM) TIER 1-GW ACCESS SYSTEM
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ITX
2012-02-08
PUREIMAGE ULTRASOUND TRANSMISSION GEL
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ITX
2011-06-28
HIGHLAND INSTRUMENTS CES AND TUS INSTRUMENT HOLDER
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ITX
2011-05-27
KONIX ULTRASOUND GEL
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ITX
2011-04-27
CUBESCAN / BIOCON-700
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ITX
2011-04-26
DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM
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ITX
2011-04-08
UF-760AG
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ITX
2011-02-08
FUJIFILM DIAGNOSTIC ULTRASOUND SYSTEM FAZONE CB
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ITX
2011-02-02
PET-512MC TRANSESOPHAGEAL TRANSDUCER
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ITX
2011-01-20
TERASON T3200 ULTRASOUND SYSTEM
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ITX
2011-01-12
APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM
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ITX
2011-01-05
THE SONOACE R5 DIAGNOSTIC ULTRASOUND SYSTEM
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ITX
2010-11-03
DC-7 DIAGNOSTIC ULTRASOUND SYSTEM, DC-3/DC-3T DIAGNOSTIC ULTRASOUND SYSTEM
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ITX
2010-10-13
AIXPLORER
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ITX
2010-08-19
STN PROBE
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ITX
2010-08-12
SONOSITE NANOMAXX SERIES ULTRASOUND SYSTEM, SONOSITE MAXX SERIES ULTRASOUND SYSTEM
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ITX
2010-07-16
THE SONOACE R3 DIAGNOSTIC ULTRASOUND SYSTEM
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ITX
2010-06-08
DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM, CONVEX ARRAY TRANSDUCER, LINEAR ARRAY
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ITX
2010-04-30
DC-7 DIAGNOSTIC ULTRASOUND SYSTEM
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ITX
2010-02-19
SONALIS
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ITX
2010-01-28
MODEL VIAMO SSA-640A, VERSION 2.0 ULTRASOUND SYSTEM
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ITX
2010-01-19
ULTRASOUND GENERAL PURPOSE GUIDANCE SYSTEM
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ITX
2009-12-10
SONOACE X8 DIAGNOSTIC ULTRASOUND SYSTEM
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ITX
2009-11-20
SONIX ULTRASOUND SCANNER
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ITX
2009-11-10
SAFERSONIC SONOGRAPHY COVER
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ITX
2009-10-15
DC-7 DIAGNOSTIC ULTRASOUND SYSTEM
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ITX
2009-09-28
GE VSCAN COMPACT DIAGNOSTIC ULTRASOUND SYSTEM
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ITX
2009-09-28
SHEATHESISO ULTRASOUND TRANSDUCER COVER
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ITX
2009-09-24
PACSCAN PLUS, MODELS 300P AND 300AP
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ITX
2009-09-02
CHISON DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM, CONVEX PROBE, LINEAR PROBE, PHASED ARRAY PROBE, TRANSVAGINAL
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ITX
2009-07-17
CX50 VERSION 2.0 DIAGNOSTIC ULTRASOUND SYSTEM AND TRANSDUCERS
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ITX
2009-07-09
DC-3/DC-3T DIAGNOSTIC ULTRASOUND SYSTEM
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ITX
2009-06-19
DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM
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ITX
2009-05-15
APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM MODEL SSA-790A VERSION 4.0
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ITX
2009-04-15
DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM, MODEL DP-6900
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ITX
2009-04-08
DIGDOP ULTRASOUND SYSTEM
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ITX
2009-02-10
HUMANSCAN M5S-D ULTRASOUND TRANSDUCER
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ITX
2009-02-02
NEEDLE GUIDE FOR 8814, MODEL UA1335, NEEDLE GUIDE FOR 8815, MODEL UA 1336, NEEDLE GUIDE FOR 8824, MODEL UA 1337
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ITX
2009-01-13
FLYING DIAGNOSTIC ULTRASOUND SYSTEM
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ITX
2008-12-15
DIAGNOSTIC ULTRASOUND SYSTEM SARANO, ECHO VIEW, SHIMASONIC
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ITX
2008-12-05
PRAGER SHELL
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ITX
2008-09-09
UF-870 AG DIAGNOSTIC ULTRASOUND SYSTEM
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ITX
2008-07-11
CX50 DIAGNOSTIC ULTRASOUND SYSTEM
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ITX
2008-06-11
USHIFU STEPPER
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ITX
2008-06-03
SOFIA AUTOMATED TOMOGRAPHIC ULTRASOUND (ATUS)
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ITX
2008-03-13
ATLANTIS 018 PERIPHERAL IMAGING CATHETER
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ITX
2008-03-11
ATLANTIS PVIMAGING CATHETER, MODEL H749364560
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ITX
2008-02-21
CLEARSCAN
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ITX
2008-01-09
ECHOVIEW / SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1100
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ITX
2008-01-09
ECHOVIEW / SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1200PRO
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ITX
2008-01-09
ECHOVIEW / SHIMASONIC DIAGNOSTIC ULTRASOUND DEVICE, MODEL SDU-2200PRO
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ITX
2007-11-13
ACUSON S2000 ULTRASOUND SYSTEM
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