COMPAX 90/15E
FDA 510(k) clearance K954356 · decided 1995-10-07
Clearance details
- K-number
- K954356
- Device name
- COMPAX 90/15E
- Applicant
- General Electric Co.
- Decision
- Substantially Equivalent
- Date received
- 1995-09-18
- Decision date
- 1995-10-07
- Days to decision
- 19 days
- Clearance type
- Traditional
- Product code
- IXR
- Device class
- 2
- Regulation number
- 892.1980
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Milwaukee, WI, US
- Third-party review
- No
- Expedited review
- No
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| ELECTROPHYSIOLOGY TILT TABLE MODEL #9660 (K965105) | U.S. Imaging Tables, Inc. | 1997-01-30 |
| FLUOROVIEW SERIES FLUOROSCOPIC TABLES (K965096) | U.S. Imaging Tables, Inc. | 1997-01-27 |
| TILTING RADIOGRAPHIC TABLE (REMOTE) (K963851) | Acoma Medical Imaging, Inc. | 1997-01-23 |
| TANGENT VI TABLE (K961022) | Fischer Imaging Corp. | 1996-05-03 |
| SURGICAL C-ARM TABLE, 9610 (K953557) | U.S. Imaging Tables, Inc. | 1995-09-26 |
| VACS TABLE, 9650 (K953556) | U.S. Imaging Tables, Inc. | 1995-09-26 |
| KOORDINAT M (K951176) | Siemens Medical Solutions USA, Inc. | 1995-04-20 |
| ULTRA-PRO ULTRASOUND SCANNING TABLE MODEL #056-650 (K950981) | Biodex Medical Systems, Inc. | 1995-04-03 |
Recalls involving this device
No recalls on record reference this clearance.
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 |