GE LOGIQ 5
FDA 510(k) clearance K014097 · decided 2002-01-10
Clearance details
- K-number
- K014097
- Device name
- GE LOGIQ 5
- Applicant
- GE Medical Systems
- Decision
- Substantially Equivalent
- Date received
- 2001-12-12
- Decision date
- 2002-01-10
- Days to decision
- 29 days
- Clearance type
- Special
- Product code
- IYN
- Device class
- 2
- Regulation number
- 892.1550
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Milwaukee, WI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| LOGIQ 5 system models 2331752, 2331753, 2332750, 2353313 and 2355477. recall (Z-0386-06) | General Electric Med Systems LLC | 2006-01-11 |