510(k) K103365
DISCOVERY 3T 16 CH BODY ARRAY COIL (ANTERIOR); DISCOVERY 3T 16 CH BODY ARRAY COIL (POSTERIOR); DISCOVERY 3T 32 CH BODY A by
Ge Healthcare Coils (Usa Instruments, Inc.)
— Product Code MOS
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 12, 2011
- Date Received
- November 17, 2010
- 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