FDA.reportPublic FDA data

Imaging Probe

Primary DI
06971679947016
Brand
Imaging Probe
Company
Wuxi Hisky Medical Technologies Co.,Ltd.
Model
FT-3.5R65
Published
2020-03-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
K173595000
K200136000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K173595000Shear Wave Quantificational Ultrasound Diagnostic SystemWuxi Hisky Medical Technologies Co., Ltd.2018-06-22IYO
K200136000Shear Wave Quantificational Ultrasound Diagnostic SystemWuxi Hisky Medical Technologies Co., Ltd.2020-03-17IYO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06971679947016PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06971679947016069716799470166971679947016

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Handling Environment Humidity30 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Handling Environment Temperature-40 Degrees Celsius70 Degrees Celsius
Storage Environment Atmospheric Pressure86 KiloPascal106 KiloPascal
Storage Environment Humidity0 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Storage Environment Temperature-5 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+8651085387702service@hiskymedical.com
+8651085387867service@hiskymedical.com

Regulatory Flags#

DUNS number
544348534
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06971679949782Confocal Microprobe Imaging SystemBrightP9802025-08-14
06971679949799Confocal Microprobe Imaging SystemBrightP9602025-08-14
06971679949805Confocal Microprobe Imaging SystemBrightP9002025-08-14
06971679949812Confocal Microprobe Imaging SystemBrightP8802025-08-14
06971679949829Confocal Microprobe Imaging SystemBrightP8602025-08-14
06971679949836Confocal Microprobe Imaging SystemBrightP7802025-08-14
06971679949843Confocal Microprobe Imaging SystemBrightP7502025-08-14
06971679949850Confocal Microprobe Imaging SystemBrightP6802025-08-14
06971679949867Confocal Microprobe Imaging SystemBrightP6602025-08-14
06971679949874Confocal Microprobe Imaging SystemBrightP6002025-08-14
06971679949881Confocal Microprobe Imaging SystemBrightP5802025-08-14
06971679949898Confocal Microprobe Imaging SystemBrightP2802025-08-14
06971679949904Confocal Microprobe Imaging SystemBrightP2002025-08-14
06971679949911Confocal Microprobe Imaging SystemBrightP1602025-08-14
06971679949928Confocal Microprobe Imaging SystemBrightP1002025-08-14
06971679949935Confocal Microprobe Imaging SystemBrightX662025-08-14
06971679948945Shear Wave Quantificational Ultrasound Diagnostic SystemMini9902025-08-05
06971679948952Shear Wave Quantificational Ultrasound Diagnostic SystemMini7902025-08-05
06971679948969Shear Wave Quantificational Ultrasound Diagnostic SystemMini7802025-08-05
06971679948976Shear Wave Quantificational Ultrasound Diagnostic SystemMini5602025-08-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850050934233EndoSound® EVS ProbeEndosound, Inc.ITX2026-06-01
04987670105937DIAGNOSTIC ULTRASOUND SYSTEMCANON INC.ITX2026-06-01
04987670106194DIAGNOSTIC ULTRASOUND SYSTEMCANON INC.ITX2026-06-01
08800013510112L8-17HAlpinion Medical Systems Co., Ltd.ITX2026-05-29
00198953121382VolusonGE Ultrasound Korea Ltd.ITX2026-05-28
08800290027266PA2-9SSAMSUNG MEDISON CO., LTD.ITX2026-04-03
08800290027419LA2-9SDSAMSUNG MEDISON CO., LTD.ITX2026-04-03
08800290028638CA2-8ADSAMSUNG MEDISON CO., LTD.ITX2026-04-03
08800290027471EV2-12SAMSUNG MEDISON CO., LTD.ITX2026-01-28
08800289975974R30 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.ITX2026-01-20
08800289976025R20 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.ITX2026-01-20
08800289979224EA2-11ARnSAMSUNG MEDISON CO., LTD.ITX2026-01-20
08800289979262CA1-7SnSAMSUNG MEDISON CO., LTD.ITX2026-01-20
08800290027297PA2-9SSAMSUNG MEDISON CO., LTD.ITX2026-01-20
08800290027334LA2-9SnSAMSUNG MEDISON CO., LTD.ITX2026-01-20
08800290027365CA3-10AnSAMSUNG MEDISON CO., LTD.ITX2026-01-20
08056304455826MyLabC25ESAOTE SPAITX2025-12-10
08056304455833MyLabC30ESAOTE SPAITX2025-12-10
08800289979132cV4 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.ITX2025-09-03
08800289981883cV5 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.ITX2025-09-03
08056304455017MyLabA50ESAOTE SPAITX2025-07-07
08056304455215MyLabE85ESAOTE SPAITX2025-07-07
08056304455307MyLabA70ESAOTE SPAITX2025-07-07
08056304455437MyLabA50ESAOTE SPAITX2025-07-07
08056304455451MyLabA70ESAOTE SPAITX2025-07-07
08056304455635MyLabE80ESAOTE SPAITX2025-07-07
08056304455642MyLabE85ESAOTE SPAITX2025-07-07
08800289970351cV8 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.ITX2025-02-27
00850055427075HYDROS TRUS ProbePROCEPT BioRobotics CorporationITX2024-09-06
08056304455628MyLabE80ESAOTE SPAITX2024-03-29