Transducer, Ultrasonic, Diagnostic

Product Code: ITX

Radiology Diagnostic Ultrasound Devices

Applicable Standards: No Standard Applicable. General Radiological Health Requirements Apply. [1000-1005]

Code of Federal Regulations: 892.1570


Radiation TypeAcoustic
Radition SafetyAbbreviated
Annual ReportsNo

Products Classified as ITX

5276Transducer, Ultrasonic, DiagnosticDiagnostic Ultrasonic Transducer.

Total Product Life Cycle (TPLC) Devices

5276Transducer, Ultrasonic, DiagnosticDiagnostic Ultrasonic Transducer.

FDA Consensus Standards

Transducer, Ultrasonic, Diagnostic [32412]21 CFR §892.1570 🔎
Transducer, Ultrasonic, Diagnostic [37049]21 CFR §892.1570 🔎
Transducer, Ultrasonic, Diagnostic [29909]21 CFR §892.1570 🔎
Transducer, Ultrasonic, Diagnostic [37172]21 CFR §892.1570 🔎

Pre-market Notifications for ITX

K211969EMM Ultrasonic Transducer CoverExact Medical Manufacturing
K202035Vscan AirGE Medical Systems Ultrasound And Primary Care Diagnostics,
K201425Disposable Intraoperative Probe (DIOP8)Huntleigh Healthcare Limited
K200733Opticross 35 15 MHz Peripheral Imaging CatheterBoston Scientific Corporation
K191491EZ-CoverMedXPress.Pro
K190802Envision Ultrasound Pad And CoverCIVCO Medical Solutions
K180970Disposable Guides KDNG00Koelis
K171348Pinpoint GT Needle Guide KitsC.R. Bard, Inc.
K171272Cook-Swartz Doppler Flow ProbeCook Incorporated
K171040Reusable Guides Ranges (PERINE Range, NAIL Range, CON-LEAD Range And LIN-LEAD Range) And STEADY PRO RangeKoelis
K170741GTK Disposable Needle GuidesGEOTEK Medikal Ltd Sti
K163502ISR'obot Biopsy KitBiobot Surgical Pte Ltd
K163313ASTRA TEE Transesophageal Probe Reprocessor, ASTRA VR Endovaginal/Endorectal Probe ReprocessorCIVCO MEDICAL INSTRUMENTS CO., INC.
K160806Verza Guidance SystemCIVCO MEDICAL INSTRUMENTS CO., INC.
K160414Precision Point Biopsy Needle GuideCorbin Clinical Resources, LLC

Global Unique Device Identification Database

00380657410774Transducer, ultrasonic, diagnostic
00380657410736Transducer, ultrasonic, diagnostic
10304040004088Transducer, ultrasonic, diagnostic
10304040004071Transducer, ultrasonic, diagnostic
10304040004064Transducer, ultrasonic, diagnostic
10304040004057Transducer, ultrasonic, diagnostic
20613994910800Transducer, ultrasonic, diagnostic
20613994910763Transducer, ultrasonic, diagnostic
20613994802488Transducer, ultrasonic, diagnostic
20613994802273Transducer, ultrasonic, diagnostic
20613994802266Transducer, ultrasonic, diagnostic
00643169020337Transducer, ultrasonic, diagnostic
00643169020269Transducer, ultrasonic, diagnostic
00643169020252Transducer, ultrasonic, diagnostic
00643169020245Transducer, ultrasonic, diagnostic

Maude Adverse Events

SITE~RITE 5 ULTRASOUND SYSTEM CLASS II SCANNERBARD ACCESS SYSTEMS2020-03-20
SITE~RITE 5 ULTRASOUND SYSTEM CLASS II SCANNERBARD ACCESS SYSTEMS2020-03-20
SITE~RITE 5 ULTRASOUND SYSTEM CLASS II SCANNERBARD ACCESS SYSTEMS2020-03-20
TRANSDUCER X8-2TPHILIPS ULTRASOUND, INC2020-03-19
S8-3T MICRO TEE TRANSDUCERPHILIPS ULTRASOUND, INC2020-03-18
ULTRASONIC PROBEOLYMPUS MEDICAL SYSTEMS CORP.2020-03-17
ULTRASONIC PROBEOLYMPUS MEDICAL SYSTEMS CORP.2020-03-16
S8-3T MICRO TEE TRANSDUCERPHILIPS ULTRASOUND, INC2020-03-10
BLADDER SCANNERDIRECT SUPPLY MANUFACTURING INC.2020-03-05
ULTRASONIC PROBEOLYMPUS MEDICAL SYSTEMS CORP.2020-02-18
TRANSDUCER X8-2TPHILIPS ULTRASOUND, INC2020-02-11
S8-3T MICRO TEE TRANSDUCERPHILIPS ULTRASOUND, INC2020-02-07
BARD PROBE COVERBARD ACCESS SYSTEMS2020-02-06
VIVID IG.E MEDICAL SYSTEMS ISRAEL LTD.2020-02-05
S8-3T MICRO TEE TRANSDUCERPHILIPS ULTRASOUND, INC2020-01-29
X7-2T TRANSDUCER (MTEE)PHILIPS ULTRASOUND, INC2020-01-24
X7-2T TRANSDUCER (MTEE)PHILIPS ULTRASOUND, INC2020-01-23
6VT-D PROBEGE VINGMED ULTRASOUND AS2020-01-10
S8-3T MICRO TEE TRANSDUCERPHILIPS ULTRASOUND, INC2020-01-10
ULTRASONIC PROBEOLYMPUS MEDICAL SYSTEMS CORP.2020-01-03
ULTRASONIC PROBEOLYMPUS MEDICAL SYSTEMS CORP.2020-01-03
TRANSDUCER X8-2TPHILIPS ULTRASOUND, INC2020-01-02
ULTRASONIC PROBEOLYMPUS MEDICAL SYSTEMS CORP.2020-01-02
ULTRASONIC PROBEOLYMPUS MEDICAL SYSTEMS CORP.2020-01-02
S8-3T MICRO TEE TRANSDUCERPHILIPS ULTRASOUND, INC2019-12-23
6VT-D PROBEGE VINGMED ULTRASOUND AS2019-12-04
SITE~RITE ULTRASOUND SYSTEM NEEDLE GUIDE KIT (18G) (POLYETHYLENE) (48IN)BARD ACCESS SYSTEMS2019-11-20
SITE~RITE ULTRASOUND SYSTEM NEEDLE GUIDE KIT (21G) (POLYETHYLENE) (48IN)BARD ACCESS SYSTEMS2019-10-31
SITE~RITE 5 ULTRASOUND SYSTEMBARD ACCESS SYSTEMS2019-10-24
SITE~RITE ULTRASOUND SYSTEM NEEDLE GUIDE KIT (21G) (POLYETHYLENE) (48IN)BARD ACCESS SYSTEMS2019-10-23
SITE~RITE PROBE COVER KIT WITH GEL (48 IN)BARD ACCESS SYSTEMS2019-10-11
COOK-SWARTZ DOPPLER PROBECOOK VANDERGRIFT INC2019-10-10
Transducer X8-2tPHILIPS ULTRASOUND, INC2019-10-10
STERILE SITE RITE U/S COVERBARD ACCESS SYSTEMS, INC.2019-10-03
SURE-POINT? TRACKERBARD BRACHYTHERAPY, INC. -14245262019-10-02
MICRO-CONVEXGE HEALTHCARE JAPAN CORPORATION2019-10-02
S8-3T MICRO TEE TRANSDUCERPHILIPS ULTRASOUND, INC2019-10-01
TRANSDUCER X8-2TPHILIPS ULTRASOUND, INC.2019-09-20
SITE~RITE PROBE COVER KIT WITH GEL (48 IN)BARD ACCESS SYSTEMS2019-09-13
ULTRASONIC PROBEOLYMPUS MEDICAL SYSTEMS CORP.2019-09-10
TRANSDUCER X7-2TPHILIPS ULTRASOUND, INC.2019-09-09
ULTRASONIC PROBEOLYMPUS MEDICAL SYSTEMS CORP.2019-09-09
SITE-RITE 5-EX SCANNERBARD ACCESS SYSTEMS2019-09-06
S8-3T MICRO TEE TRANSDUCERPHILIPS ULTRASOUND, INC2019-09-06
SITE-RITE 8 ULTRASOUND SYSTEM W/PINPOINT GTBARD ACCESS SYSTEMS2019-09-06
SITE~RITE ULTRASOUND SYSTEM NEEDLE GUIDE KIT (21G) (POLYETHYLENE) (48IN)BARD ACCESS SYSTEMS2019-08-30
SITE~RITE 5 ULTRASOUND SYSTEM CLASS II SCANNERBARD ACCESS SYSTEMS2019-08-29
SITE~RITE HALCYON ULTRASOUND SYSTEMBARD ACCESS SYSTEMS2019-08-28
S8-3T MICRO TEE TRANSDUCERPHILIPS ULTRASOUND, INC2019-08-26
S8-3T MICRO TEE TRANSDUCERPHILIPS ULTRASOUND, INC2019-08-26

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