GE LOGIQ P6
FDA 510(k) clearance K073297 · decided 2007-12-18
Clearance details
- K-number
- K073297
- Device name
- GE LOGIQ P6
- Applicant
- General Electric Co.
- Decision
- Substantially Equivalent
- Date received
- 2007-11-23
- Decision date
- 2007-12-18
- Days to decision
- 25 days
- Clearance type
- Special
- Product code
- IYN
- Device class
- 2
- Regulation number
- 892.1550
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Wauwatosa, WI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| GE HEALTHCARE LOGIQ P6 Premium TruScan(TM) Imagining Technology: (a) Model BT09 (b) Model recall (Z-0788-2019) | GE Healthcare, LLC | 2019-01-30 |
| GE LOGIQ P6 Ultrasound System. The device is intended for use by a qualified physician for recall (Z-0834-2012) | GE Healthcare, LLC | 2012-01-21 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS (P830074/S017) | General Electric Co. | 1988-07-29 |
| GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS (P830074/S013) | General Electric Co. | 1988-07-15 |
| GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS (P830074/S016) | General Electric Co. | 1988-06-30 |
| GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS (P830074/S014) | General Electric Co. | 1988-05-05 |
| GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS (P830074/S015) | General Electric Co. | 1988-05-02 |
| GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS (P830074/S012) | General Electric Co. | 1987-11-25 |
| GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS (P830074/S011) | General Electric Co. | 1987-06-18 |
| GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS (P830074/S010) | General Electric Co. | 1987-03-30 |