Shear Wave Quantificational Ultrasound Diagnostic System— 510(k) K173595
Substantially EquivalentWuxi Hisky Medical Technologies Co., Ltd.
FDA 510(k) clearance K173595 for Shear Wave Quantificational Ultrasound Diagnostic System, Substantially Equivalent on 2018-06-22. Applicant: Wuxi Hisky Medical Technologies Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Wuxi Hisky Medical Technologies Co., Ltd.
- Product code
- Code IYO
- Device class
- Class 2
- Regulation
- 21 CFR 892.1560
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Wuxi, CN
Recent devices under product code IYO
view allMore clearances from Wuxi Hisky Medical Technologies Co., Ltd.
view all- K250026 — Shear Wave Quantificational Ultrasound Diagnostic System (FH9000/FH7000/FH6000/FH5000/FH3000/FH1000)
- K243711 — Confocal Microprobe Imaging System (10 models)
- K243880 — Shear Wave Quantificational Ultrasound Diagnostic System (Mini900, Mini990, Mini800, Mini790, Mini780, Mini560, Mini300, Mini100, FT100)
- K200136 — Shear Wave Quantificational Ultrasound Diagnostic System
Adverse events under product code IYO
product code IYO- Malfunction
- 3,339
- Total
- 3,339
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.