LC, CARDIAC POSITIONER #B5078A
FDA 510(k) clearance K890348 · decided 1989-02-27
Clearance details
- K-number
- K890348
- Device name
- LC, CARDIAC POSITIONER #B5078A
- Applicant
- General Electric Co.
- Decision
- Substantially Equivalent
- Date received
- 1989-01-23
- Decision date
- 1989-02-27
- Days to decision
- 35 days
- Clearance type
- Traditional
- Product code
- IZI
- Device class
- 2
- Regulation number
- 892.1600
- 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 |
|---|---|---|
| Advantx 1 LC1 Model 46-279781P1 Angiographic X-ray System recall (Z-0896-04) | General Electric Med Systems | 2004-07-20 |
| Advantx 1 LC1 Model 45258230 Angiographic X-ray System recall (Z-0897-04) | General Electric Med Systems | 2004-07-20 |
| Advantx 1 LC2 Model 45562281 Angiographic X-ray System recall (Z-0898-04) | General Electric Med Systems | 2004-07-20 |
| Advantx 1 LC2 Model 2105657 Angiographic X-ray System recall (Z-0899-04) | General Electric Med Systems | 2004-07-20 |
| Advantx 1 SC Model 36006617 Angiographic X-ray System recall (Z-0900-04) | General Electric Med Systems | 2004-07-20 |
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 |