510(k) K213480
K213480 is an FDA 510(k) premarket notification submitted by Rapid Biomedical GmbH for the device "31P/1H Head Coil, 23Na/1H Head Coil, 13C/1H Head Coil". The FDA issued a decision of Substantially Equivalent on Feb 1, 2023. The device falls under product code MOS (Coil, Magnetic Resonance, Specialty), a Class II device regulated under 21 CFR 892.1000. Rapid Biomedical GmbH has 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 1, 2023
- Date Received
- Oct 29, 2021
- 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
- 510(k)