510(k) K110591
K110591 is an FDA 510(k) premarket notification submitted by Mr Instruments, Inc. for the device "MC 1504G-16R, 1.5T, 16-CHANNEL, MC 3004G-16R, 3.0T, 16-CHANNEL HEAD COIL". The FDA issued a decision of Substantially Equivalent on Mar 29, 2011. The device falls under product code MOS (Coil, Magnetic Resonance, Specialty), a Class II device regulated under 21 CFR 892.1000. Mr Instruments, Inc. has 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 29, 2011
- Date Received
- Mar 2, 2011
- 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
- 510(k)