ITX
ACUSON L538 TRANSDUCER
- Advisory panel
- Radiology
- Total cleared
- 409
Adverse events under product code ITX
product code ITX- Death
- 6
- Injury
- 137
- Malfunction
- 2,036
- Total
- 2,179
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code ITX
1–100 of 409- K250883 — ULTRASONIC PROBE UM-3R (UM-3R); ULTRASONIC PROBE UM-G20-29R (UM-G20-29R)
- K250762 — ULTRASONIC PROBE UM-S20-17S (UM-S20-17S); ULTRASONIC PROBE UM-S20-20R (UM-S20-20R)
- K250524 — Mendaera Guidance System
- K250469 — Accuro® 3S Needle Guide Kit
- K241662 — Ultrasound Transducer Cover
- K233965 — UltraDrape UGPIV Barrier and Securement (34-15)
- K241615 — Transducer Probe Cover
- K233109 — TP Pivot Pro Needle Guide
- K231666 — Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L)
- K231783 — VitroPRO
- K223689 — Disposable Needle Guides and Grids
- K222460 — Intraoperative Ultrasound Probe Cover
- K221278 — Transducer Probe Cover
- K222052 — VitroPRO
- K213087 — Natural Rubber Latex Ultrasound Transducer Probe Covers
- K211270 — CIV-Clear cover
- K211969 — EMM Ultrasonic Transducer Cover
- K201425 — Disposable Intraoperative Probe (DIOP8)
- K202035 — Vscan Air
- K191491 — EZ-Cover
- K200733 — Opticross 35 15 MHz Peripheral Imaging Catheter
- K190802 — Envision ultrasound pad and cover
- K171272 — Cook-Swartz Doppler Flow Probe
- K180970 — Disposable guides KDNG00
- K171040 — Reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) and STEADY PRO range
- K163313 — ASTRA TEE Transesophageal Probe Reprocessor, ASTRA VR Endovaginal/Endorectal Probe Reprocessor
- K170741 — GTK Disposable Needle Guides
- K171348 — Pinpoint GT Needle Guide Kits
- K163502 — iSR'obot Biopsy Kit
- K170338 — A-View
- K152126 — UST-5550-R; UST-5536-R; L43K
- K160806 — Verza Guidance System
- K160414 — Precision Point Biopsy Needle Guide
- K153212 — Sheathes Ultrasound Probe Covers
- K152403 — Permanent Sled Bag
- K142618 — Intra-operative Ultrasound Transducer, PROSOUND ALPHA 7 Diagnostic Ultrasound System, ARIETTA 70 Diagnostic Ultrasound System
- K141334 — REUSABLE GUIDE
- K140854 — INTRA-OPERATIVE ULTRASOUND TRANSDUCER
- K141093 — 6VT-D ULTRASOUND TRANSDUCER
- K131161 — EX3 STEPPER, CLASSIC STEPPER, MULTI-PURPOSE WORKSTATION STEPPER; MICRO-TOUCH, MICRO-TOUCH LP, MULIT-PURPOSE WORKSTATION,
- K131528 — NON-PYROGENIC ULTRASOUND TRANSDUCER COVER
- K123424 — MDU5 PLUS STERILE BAG
- K122921 — C1-6-D ULTRASOUND TRANSDUCER
- K122515 — C2-9-D ULTRASOUND TRANSDUCER
- K121062 — VIVID I DIAGNOSTIC ULTRASOUND SYSTEM, VIVID Q DIAGNOSTIC ULTRASOUND SYSTEM
- K121807 — V5MS TRANSDUCER
- K113832 — SONICEYE ULTRASOUND TRANSDUCER
- K111426 — EUCLID (TM) TIER 1-GW ACCESS SYSTEM
- K120156 — PUREIMAGE ULTRASOUND TRANSMISSION GEL
- K110752 — HIGHLAND INSTRUMENTS CES AND TUS INSTRUMENT HOLDER
- K101952 — KONIX ULTRASOUND GEL
- K111021 — CUBESCAN / BIOCON-700
- K110999 — DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM
- K110920 — UF-760AG
- K110202 — FUJIFILM DIAGNOSTIC ULTRASOUND SYSTEM FAZONE CB
- K103629 — PET-512MC TRANSESOPHAGEAL TRANSDUCER
- K110020 — TERASON T3200 ULTRASOUND SYSTEM
- K103645 — APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM
- K103722 — THE SONOACE R5 DIAGNOSTIC ULTRASOUND SYSTEM
- K102865 — DC-7 DIAGNOSTIC ULTRASOUND SYSTEM, DC-3/DC-3T DIAGNOSTIC ULTRASOUND SYSTEM
- K102041 — AIXPLORER
- K101816 — STN PROBE
- K101757 — SONOSITE NANOMAXX SERIES ULTRASOUND SYSTEM, SONOSITE MAXX SERIES ULTRASOUND SYSTEM
- K101829 — THE SONOACE R3 DIAGNOSTIC ULTRASOUND SYSTEM
- K101008 — DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM, CONVEX ARRAY TRANSDUCER, LINEAR ARRAY
- K101041 — DC-7 DIAGNOSTIC ULTRASOUND SYSTEM
- K100204 — SONALIS
- K100067 — MODEL VIAMO SSA-640A, VERSION 2.0 ULTRASOUND SYSTEM
- K093713 — ULTRASOUND GENERAL PURPOSE GUIDANCE SYSTEM
- K093714 — SONOACE X8 DIAGNOSTIC ULTRASOUND SYSTEM
- K093462 — SONIX ULTRASOUND SCANNER
- K092858 — SAFERSONIC SONOGRAPHY COVER
- K092691 — DC-7 DIAGNOSTIC ULTRASOUND SYSTEM
- K091828 — SHEATHESISO ULTRASOUND TRANSDUCER COVER
- K092756 — GE VSCAN COMPACT DIAGNOSTIC ULTRASOUND SYSTEM
- K092637 — PACSCAN PLUS, MODELS 300P AND 300AP
- K091877 — CHISON DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM, CONVEX PROBE, LINEAR PROBE, PHASED ARRAY PROBE, TRANSVAGINAL
- K091804 — CX50 VERSION 2.0 DIAGNOSTIC ULTRASOUND SYSTEM AND TRANSDUCERS
- K091941 — DC-3/DC-3T DIAGNOSTIC ULTRASOUND SYSTEM
- K091680 — DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM
- K091295 — APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM MODEL SSA-790A VERSION 4.0
- K090912 — DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM, MODEL DP-6900
- K090465 — DIGDOP ULTRASOUND SYSTEM
- K083824 — HUMANSCAN M5S-D ULTRASOUND TRANSDUCER
- K083667 — NEEDLE GUIDE FOR 8814, MODEL UA1335, NEEDLE GUIDE FOR 8815, MODEL UA 1336, NEEDLE GUIDE FOR 8824, MODEL UA 1337
- K083877 — FLYING DIAGNOSTIC ULTRASOUND SYSTEM
- K082224 — DIAGNOSTIC ULTRASOUND SYSTEM SARANO, ECHO VIEW, SHIMASONIC
- K082893 — PRAGER SHELL
- K081919 — UF-870 AG DIAGNOSTIC ULTRASOUND SYSTEM
- K081802 — CX50 DIAGNOSTIC ULTRASOUND SYSTEM
- K080970 — USHIFU STEPPER
- K080555 — SOFIA AUTOMATED TOMOGRAPHIC ULTRASOUND (ATUS)
- K073623 — ATLANTIS 018 PERIPHERAL IMAGING CATHETER
- K080272 — ATLANTIS PVIMAGING CATHETER, MODEL H749364560
- K080119 — CLEARSCAN
- K071287 — ECHOVIEW / SHIMASONIC DIAGNOSTIC ULTRASOUND DEVICE, MODEL SDU-2200PRO
- K071289 — ECHOVIEW / SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1200PRO
- K071291 — ECHOVIEW / SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1100
- K072786 — ACUSON S2000 ULTRASOUND SYSTEM
- K072918 — MODEL SSA-680A XARIO XG DIAGNOSTIC ULTRASOUND SYSTEM, VERSION 1.00
Data sourced from openFDA. This site is unofficial and independent of the FDA.