FDA · official record K250026Substantially EquivalentShear Wave Quantificational Ultrasound Diagnostic System (FH9000/FH7000/FH6000/FH5000/FH3000/FH1000)
United StatesIYNWuxi Hisky Medical Technologies Co., Ltd.
Official record identity
- FDA application number
- K250026
- Decision date
- October 01, 2025
- Published decision
- Substantially Equivalent
Classification
Published parties
Additional source fields
- Decision code
- SESE
- Published decision
- Substantially Equivalent
- Submission type
- Traditional
- Received date
- 2025-01-06
- Review panel
- Radiology
- Current product-code class (harmonized)
- 2
- Current product-code regulation (harmonized)
- 892.1550
About this record
This record preserves an application published in the FDA 510(k) bulk export, including the DEN entries FDA includes in that export. Historical decisions do not establish current marketing status. Product-code harmonization is separate from the original application; joined establishment identifiers are not assigned to the applicant. The complete official export is checked daily and raw evidence is retained.