Shear Wave Quantificational Ultrasound Diagnostic System (Mini900, Mini990, Mini800, Mini790, Mini780, Mini560, Mini300, Mini100, FT100)
FDA 510(k) clearance K243880 · decided 2025-06-17
Clearance details
- K-number
- K243880
- Device name
- Shear Wave Quantificational Ultrasound Diagnostic System (Mini900, Mini990, Mini800, Mini790, Mini780, Mini560, Mini300, Mini100, FT100)
- Applicant
- Wuxi Hisky Medical Technologies Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2024-12-18
- Decision date
- 2025-06-17
- Days to decision
- 181 days
- Clearance type
- Traditional
- Product code
- IYO
- Device class
- 2
- Regulation number
- 892.1560
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Wuxi, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.