MC 1504G-16R, 1.5T, 16-CHANNEL, MC 3004G-16R, 3.0T, 16-CHANNEL HEAD COIL
FDA 510(k) clearance K110591 · decided 2011-03-29
Clearance details
- K-number
- K110591
- Device name
- MC 1504G-16R, 1.5T, 16-CHANNEL, MC 3004G-16R, 3.0T, 16-CHANNEL HEAD COIL
- Applicant
- Mr Instruments, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2011-03-02
- Decision date
- 2011-03-29
- Days to decision
- 27 days
- Clearance type
- Traditional
- Product code
- MOS
- Device class
- 2
- Regulation number
- 892.1000
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Minnetonka, MN, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.