510(k) K231085
K231085 is an FDA 510(k) premarket notification submitted by Shenzhen RF Tech Co., Ltd. for the device "1.5T HD T/R Knee Array (10-F34127)". The FDA issued a decision of Substantially Equivalent on August 18, 2023. 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
- August 18, 2023
- Date Received
- April 17, 2023
- 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