510(k) K252587

HD 8Ch Wrist Array by Shenzhen RF Tech Co., Ltd. — Product Code MOS

K252587 is an FDA 510(k) premarket notification submitted by Shenzhen RF Tech Co., Ltd. for the device "HD 8Ch Wrist Array". The FDA issued a decision of Substantially Equivalent on April 14, 2026. The device falls under product code MOS (Coil, Magnetic Resonance, Specialty), a Class II device regulated under 21 CFR 892.1000. Shenzhen RF Tech Co., Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 14, 2026
Date Received
August 15, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Coil, Magnetic Resonance, Specialty
Device Class
Class II
Regulation Number
892.1000
Review Panel
RA
Submission Type