LEGACY/LEGACY-D TABLE
FDA 510(k) clearance K973039 · decided 1997-10-16
Clearance details
- K-number
- K973039
- Device name
- LEGACY/LEGACY-D TABLE
- Applicant
- GE Medical Systems
- Decision
- Substantially Equivalent
- Date received
- 1997-08-14
- Decision date
- 1997-10-16
- Days to decision
- 63 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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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| VISION R/F TILTING TABLE (K000412) | Villa Sistemi Medicali S.P.A. | 2000-04-24 |
| CAP-35B III/CINE 275 (K971128) | Jamieson Film Co. | 1997-04-28 |
| PHILIPS EASY DIAGNOST (K970640) | Philips Medical Systems North America, Inc. | 1997-03-21 |
| 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 |
| COMPAX 90/15E (K954356) | General Electric Co. | 1995-10-07 |
| 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
| Record | Firm | Date |
|---|---|---|
| Table Patient Step on RFX/SFX, Legacy, and Precision 500D systems recall (Z-2179-2017) | GE Healthcare, LLC | 2017-05-22 |
| GE Healthcare Precision 500D and Advantx Legacy/Legacy-D Radiographic and Fluoroscopic Sys recall (Z-1966-2015) | GE Healthcare | 2015-07-02 |
| GE Healthcare, Precision 500D, Legacy, RFX, and SFX X. This table is intended for use in a recall (Z-0012-2014) | GE Healthcare, LLC | 2013-10-17 |
| Advantx Legacy Radiographic and Fluoroscopic systems, model 2102424, 2118104, 2157009, 218 recall (Z-1611-2008) | GE Healthcare | 2008-09-19 |