| Primary Device ID | 06971679948990 |
| NIH Device Record Key | 073c7794-98d8-4fd0-a5f6-7664e6467606 |
| Commercial Distribution Discontinuation | 2025-08-05 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Shear Wave Quantificational Ultrasound Diagnostic System |
| Version Model Number | Mini100 |
| Company DUNS | 544348534 |
| Company Name | Wuxi Hisky Medical Technologies Co.,Ltd. |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 06971679948990 [Primary] |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[06971679948990]
Liquid Chemical
[06971679948990]
Liquid Chemical
[06971679948990]
Liquid Chemical
[06971679948990]
Liquid Chemical
[06971679948990]
Liquid Chemical
[06971679948990]
Liquid Chemical
[06971679948990]
Liquid Chemical
[06971679948990]
Liquid Chemical
[06971679948990]
Liquid Chemical
[06971679948990]
Liquid Chemical
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-08-13 |
| Device Publish Date | 2025-08-05 |
| 06971679945005 | FT9000 |
| 06971679949072 | Mini800 |
| 06971679949065 | FT100 |
| 06971679949577 | Mini900 |
| 06971679948990 | Mini100 |
| 06971679948983 | Mini300 |
| 06971679948976 | Mini560 |
| 06971679948969 | Mini780 |
| 06971679948952 | Mini790 |
| 06971679948945 | Mini990 |