510(k) K163205
K163205 is an FDA 510(k) premarket notification submitted by Ge Healthcare Coils (Usa Instruments, Inc.) for the device "48CH Head Coil". The FDA issued a decision of Substantially Equivalent on January 12, 2017. The device falls under product code MOS (Coil, Magnetic Resonance, Specialty), a Class II device regulated under 21 CFR 892.1000. Ge Healthcare Coils (Usa Instruments, Inc.) has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 12, 2017
- Date Received
- November 15, 2016
- 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