510(k) K222325
K222325 is an FDA 510(k) premarket notification submitted by Invivo Corporation (Business Trade Name: Philips) for the device "8ch Wrist Coil". The FDA issued a decision of Substantially Equivalent on August 31, 2022. The device falls under product code MOS (Coil, Magnetic Resonance, Specialty), a Class II device regulated under 21 CFR 892.1000. Invivo Corporation (Business Trade Name: Philips) has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 31, 2022
- Date Received
- August 2, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Coil, Magnetic Resonance, Specialty
- Device Class
- Class II
- Regulation Number
- 892.1000
- Review Panel
- RA
- Submission Type