1.5 GE 6-CHANNEL PHASED ARRAY FLEX COIL, 3.0 GE 6-CHANNEL PHASED ARRAY FLEX COIL
FDA 510(k) clearance K110610 · decided 2011-04-01
Clearance details
- K-number
- K110610
- Device name
- 1.5 GE 6-CHANNEL PHASED ARRAY FLEX COIL, 3.0 GE 6-CHANNEL PHASED ARRAY FLEX COIL
- Applicant
- Ge Medical Systems, LLC
- Decision
- Substantially Equivalent
- Date received
- 2011-03-03
- Decision date
- 2011-04-01
- Days to decision
- 29 days
- Clearance type
- Special
- Product code
- MOS
- Device class
- 2
- Regulation number
- 892.1000
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Waukesha, WI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| GE Healthcare, 3.0T 6 Channel Phased Array Flex Coil, M0050SS. Product Usage The 3.0T GE 6 recall (Z-0553-2016) | GE Medical Systems, LLC | 2015-12-28 |