FDA UDI
In Commercial Distribution
🇺🇸 United States
Shear Wave Quantificational Ultrasound Diagnostic System
DI: 06971679948969
·
Model: Mini780
·
Wuxi Hisky Medical Technologies Co.,Ltd.
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Shear Wave Quantificational Ultrasound Diagnostic System
- Primary DI
- 06971679948969
- Version / Model
- Mini780
- Company Name
- Wuxi Hisky Medical Technologies Co.,Ltd.
- Labeler DUNS
- 544348534
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-08-05
- Public Version
- 2
- Public Version Date
- 2025-12-29
- Public Version Status
- Update
- Public Device Record Key
- 72ec7f5f-f35d-48b2-8467-09ed4de58fc2
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- Yes
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Liquid Chemical
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | Radiology | 892.1550 | 2 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | Radiology | 892.1560 | 2 |
| ITX | Transducer, Ultrasonic, Diagnostic | Radiology | 892.1570 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58710 | Hepatic ultrasound elastography system | An 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). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06971679948969 | GS1 |