FDA.reportPublic FDA data

EV5C Abdominal Transducer

Primary DI
00628055481096
Brand
EV5C Abdominal Transducer
Company
Exact Imaging Inc
Model
EV5C
Catalog number
EV-5C
Device description
EV5C is an abdominal end-fire transducer.
Published
2021-02-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
ITXTransducer, Ultrasonic, Diagnostic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITXTransducer, Ultrasonic, DiagnosticRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K190995000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K190995000ExactVu High Resolution Micro-Ultrasound SystemExact Imaging, Inc.2019-05-10IYN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00628055481096PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00628055481096006280554810966280554810960628055481096

GMDN Terms#

Term, Definition table
TermDefinition
Extracorporeal ultrasound imaging transducer, hand-heldA hand-held noninvasive component of an ultrasound imaging assembly designed to be moved over the intact surface of a patient's body, typically with a coupling gel, during a variety of extracorporeal ultrasound imaging procedures (non-dedicated). Sometimes referred to as an ultrasound probe, it converts electric voltages into ultrasound which it transmits, detects resulting echoes, and transmits a proportional signal/data to an ultrasound system controller for image processing and display. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
203044268
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00628055481225EV29L Non-Sterile Reusable PrecisionPoint AdapterEV-BIOGR-PPEV-BIOGR-PP2025-05-05
00628055481058Needle Guide for use with the Exact Imaging EV29L TransducerSingle UnitEV-BIOG-12017-02-08
00628055481102Sterile transperineal needle guide with sheathSingle UnitEV-29L-TPK-12021-02-03
00628055481157Sterile transrectal needle guide with sheathSingle UnitEV-29L-TRK-12021-02-03
00628055481140Non-Sterile Reusable Needle Guide - 16GAEV-BIOG-R16EV-BIOG-R162022-05-13
00628055481089Reusable Needle Guide for use with the Exact Imaging EV29L Transducer Single UnitEV-BIOGR2018-06-01
10628055481116Sterile transperineal needle guide with sheathSingle UnitEV-29L-TPK-12021-02-03
10628055481161Sterile transrectal needle guide with sheathSingle UnitEV-29L-TRK-12021-02-03
20628055481076Needle Guide for use with the Exact Imaging EV29L TransducerSingle UnitEV-BIOG-12017-02-08
00628055481010ExactVu High Resolution Micro-Ultrasound System1.0EV-SYS-2202017-02-08
00628055481027ExactVu High Resolution Micro-Ultrasound System1.0EV-SYS-1202017-02-08
00628055481034EV29L Transrectal TransducerEV29LEV-29L2017-02-08
00628055481041EV9C Transrectal TransducerEV9CEV-9C2017-02-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00195278985613NAGE Medical Systems (China) Co.,Ltd.ITX2026-09-24
00198953126073VividGE Vingmed Ultrasound A/SITX2026-09-21
00198953172384VividGE Vingmed Ultrasound A/SITX2026-09-21
00198953172551VividGE Vingmed Ultrasound A/SITX2026-09-21
00884838128095Affiniti 50 Diagnostic Ultrasound SystemPhilips Ultrasound LLCITX2026-09-18
00884838128101Affiniti 70 Diagnostic Ultrasound SystemPhilips Ultrasound LLCITX2026-09-18
00884838128118Affiniti 30 Diagnostic Ultrasound SystemPhilips Ultrasound LLCITX2026-09-18
00884838128125EPIQ Elite Diagnostic Ultrasound SystemPhilips Ultrasound LLCITX2026-09-18
03701104600420T-LiteSONOSCANNERITX2026-08-25
04580826920721PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826920769PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
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04580826928291PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
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04580826928703PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
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08800290029376CA2-13MSAMSUNG MEDISON CO., LTD.ITX2026-08-18
08800290036169PA2-9SSAMSUNG MEDISON CO., LTD.ITX2026-08-18
08800290036237BCC2-13SAMSUNG MEDISON CO., LTD.ITX2026-08-18
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08800357300165V7 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.ITX2026-08-18
08800357308208V8 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.ITX2026-08-18