Shear Wave Quantificational Ultrasound Diagnostic System (Mini900, Mini990, Mini800, Mini790, Mini780, Mini560, Mini300, Mini100, FT100)
FDA 510(k) K243880 · Wuxi Hisky Medical Technologies Co., Ltd.
510(k) numberK243880
Submission
- Device name
- Shear Wave Quantificational Ultrasound Diagnostic System (Mini900, Mini990, Mini800, Mini790, Mini780, Mini560, Mini300, Mini100, FT100)
- Applicant
- Wuxi Hisky Medical Technologies Co., Ltd.
Wuxi, CN - Received
- December 18, 2024
- Decision date
- June 17, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Shear Wave Quantificational Ultrasound Diagnostic System (Mini900, Mini990, Mini800, Mini790, Mini780, Mini560, Mini300, Mini100, FT100) cleared by the FDA?
Shear Wave Quantificational Ultrasound Diagnostic System (Mini900, Mini990, Mini800, Mini790, Mini780, Mini560, Mini300, Mini100, FT100) (K243880) received a 510(k) decision of Substantially Equivalent on June 17, 2025, 181 days after the submission was received.
What is the product code of K243880?
The FDA product code is IYO – System, Imaging, Pulsed Echo, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1560.