FDA.reportPublic FDA data

Shear Wave Quantificational Ultrasound Diagnostic System

Primary DI
06971679948990
Brand
Shear Wave Quantificational Ultrasound Diagnostic System
Company
Wuxi Hisky Medical Technologies Co.,Ltd.
Model
Mini100
Published
2025-08-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
ITXTransducer, Ultrasonic, Diagnostic
IYNSystem, Imaging, Pulsed Doppler, Ultrasonic
IYOSystem, Imaging, Pulsed Echo, Ultrasonic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITXTransducer, Ultrasonic, DiagnosticRadiology2
IYNSystem, Imaging, Pulsed Doppler, UltrasonicRadiology2
IYOSystem, Imaging, Pulsed Echo, UltrasonicRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06971679948990PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06971679948990069716799489906971679948990

GMDN Terms#

Term, Definition table
TermDefinition
Hepatic ultrasound elastography systemAn assembly of mains electricity (AC-powered) devices, which may include rechargeable batteries, designed to measure liver stiffness/ultrasonic attenuation of tissues based on transient elastography for the evaluation/diagnosis of hepatic disease (e.g., liver fibrosis/steatosis); it may additionally be intended to measure spleen stiffness as an adjunct evaluation. It is typically used during diagnosis of chronic liver conditions such as viral hepatits, alcoholic hepatitis, and biliary disease, or for post-transplant evaluation. It consists of both a generator with dedicated software and a noninvasive applicator(s).

Sterilization Methods#

Method table
Method
Liquid Chemical

Regulatory Flags#

DUNS number
544348534
Device count
1
DM exempt
true
Serial number
true
Manufacturing date on label
true
Sterilization required before use
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

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