GENESIS 180
FDA 510(k) clearance K883863 · decided 1988-10-21
Clearance details
- K-number
- K883863
- Device name
- GENESIS 180
- Applicant
- Fischer Imaging Corp.
- Decision
- Substantially Equivalent
- Date received
- 1988-09-13
- Decision date
- 1988-10-21
- Days to decision
- 38 days
- Clearance type
- Traditional
- Product code
- IXR
- Device class
- 2
- Regulation number
- 892.1980
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Denver, CO, 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 |
| LEGACY/LEGACY-D TABLE (K973039) | GE Medical Systems | 1997-10-16 |
| 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 |
Recalls involving this device
No recalls on record reference this clearance.