HD 8Ch Wrist Array— 510(k) K252587
Substantially EquivalentShenzhen RF Tech Co., Ltd.
FDA 510(k) clearance K252587 for HD 8Ch Wrist Array, Substantially Equivalent on 2026-04-14. Applicant: Shenzhen RF Tech Co., Ltd.. Device class: 2.
Summary
Shenzhen RF Tech's HD 8Ch Wrist Array is filed under product code MOS (Coil, Magnetic Resonance, Specialty).
Class II, 21 CFR 892.1000. Radiology is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Shenzhen RF Tech filed from Shenzhen, China. The decision came 242 calendar days after FDA received it (August 15, 2025 to April 14, 2026).
Clearance details
- Applicant
- Shenzhen RF Tech Co., Ltd.
- Product code
- Product code MOS
- Device class
- Class 2
- Regulation
- 21 CFR 892.1000
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shenzhen, CN
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More clearances from Shenzhen RF Tech Co., Ltd.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.