FDA.reportPublic FDA data

C9-4v Transducer

Primary DI
04719873000050
Brand
C9-4v Transducer
Company
QISDA CORPORATION
Model
989605463411
Published
2018-01-08
Public version status
Update
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04719873000050PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719873000050047198730000504719873000050

GMDN Terms#

Term, Definition table
TermDefinition
Rectal/vaginal ultrasound imaging transducerAn invasive component of an ultrasound imaging assembly designed to be positioned within the vagina and/or rectum, either manually or under endoscopic guidance, for ultrasound imaging from within the vagina/rectum. 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 another device for display; it does not include an integrated display. It may be intended for wired or wireless data transfer and may be intended for use with a dedicated ultrasound system or with an off-the-shelf device (e.g., smartphone) with dedicated software installed. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
656079068
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04719873009480"Esaote MyLabX1" Ultrasound Transducer_Convex Linear ArrayC62B_T33002026-10-01
04719873009510"Esaote MyLabX1" Ultrasound Transducer_Linear ArrayL154BH_T33002026-10-01
04719873009534"Esaote MyLabX1" Ultrasound Transducer_Phased ArrayP42B6_T33002026-10-01
04719873000524InnoSight Diagnostic Ultrasound System6000000302842026-05-04
04719873001125Esaote MyLabX1 Diagnostic Ultrasound SystemT33002026-04-22
04719873009930Esaote MyLabX1 Ultrasound Transducer_Linear ArrayL154BH_T33002026-04-22
04719873009947Esaote MyLabX1 Ultrasound Transducer_Convex Linear ArrayC62B_T33002026-04-22
04719873009954Esaote MyLabX1 Ultrasound Transducer_Phased ArrayP42B6_T33002026-04-22
04719873000517InnoSight Diagnostic Ultrasound System9896054861322021-12-14
04719873000319InnoSight Diagnostic Ultrasound System9896054861312021-09-24
04719873000258InnoSight Diagnostic Ultrasound System9896054635212019-09-23
04719873000333InnoSight Diagnostic Ultrasound System9896054861312019-09-23
04719873009183C83B Transducer9896067004412019-09-23
04719873000265InnoSight Diagnostic Ultrasound System9896054635212019-03-09
04719873000012InnoSight Diagnostic Ultrasound System9896054635212018-01-08
04719873000036C6-2 Transducer9896054633912018-01-08
04719873000043L12-4 Transducer9896054634012018-01-18
04719873000067S4-2 Transducer9896054634212018-03-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198953083246VolusonGE Healthcare Austria GmbH & Co OGITX2026-10-09
00198953083253VolusonGE Healthcare Austria GmbH & Co OGITX2026-10-09
00198953083260VolusonGE Healthcare Austria GmbH & Co OGITX2026-10-09
06948941160022Bladder ScannerMeda Co., LtdITX2026-10-08
04719873009510"Esaote MyLabX1" Ultrasound Transducer_Linear ArrayQISDA CORPORATIONITX2026-10-01
04719873009534"Esaote MyLabX1" Ultrasound Transducer_Phased ArrayQISDA CORPORATIONITX2026-10-01
06975424191037Exact Medical Manufacturing, Inc.EXACT MEDICAL MANUFACTURING, INC.ITX2026-10-01
08809887550170EdgeFlow UH10CEdgeCare Inc.ITX2026-09-30
08809887550187EdgeFlow UH10EEdgeCare Inc.ITX2026-09-30
00860007188367FUJIFILMFujifilm Healthcare Americas CorporationITX2026-09-29
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
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