510(k) K934574
- Device
- MODEL MPFT-01, GENESIS
- Applicant
- INTERNATIONAL MEDICAL DESIGNS, INC.
- 510(k) number
- K934574
- Product code
- IXR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1994-03-04
- Date received
- 1993-09-16
- Regulation
- 892.1980
- Classification name
- Table, Radiographic, Tilting
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- GEORGE GRABOWSKI
- Address
- 303 Elnora Ave. Deltona FL US 32738 32738
FDA Registration Numbers#
- 1225473
- 3008284470
- 9610903
- 3015276088
- 3007912863
- 2243057
- 9616014
- 3033525986
- 3033527770
- 3003927316
- 8022065
- 8030233
- 3009077524
- 3004977335
- 3002808176
- 3003768251
- 2529571
- 1223864
- 9613445
- 3010496070
- 3000126629
- 3012010520
- 3013846070
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code IXR #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K000412 | VISION R/F TILTING TABLE | Villa Sistemi Medicali S.P.A. | 2000-04-24 |
| K973039 | LEGACY/LEGACY-D TABLE | GE Medical Systems | 1997-10-16 |
| K971128 | CAP-35B III/CINE 275 | Jamieson Film Co. | 1997-04-28 |
| K970640 | PHILIPS EASY DIAGNOST | Philips Medical Systems North America, Inc. | 1997-03-21 |
| K965105 | ELECTROPHYSIOLOGY TILT TABLE MODEL #9660 | U.S. Imaging Tables, Inc. | 1997-01-30 |
| K965096 | FLUOROVIEW SERIES FLUOROSCOPIC TABLES | U.S. Imaging Tables, Inc. | 1997-01-27 |
| K963851 | TILTING RADIOGRAPHIC TABLE (REMOTE) | Acoma Medical Imaging, Inc. | 1997-01-23 |
| K961022 | TANGENT VI TABLE | Fischer Imaging Corp. | 1996-05-03 |
| K954356 | COMPAX 90/15E | General Electric Co. | 1995-10-07 |
| K953557 | SURGICAL C-ARM TABLE, 9610 | U.S. Imaging Tables, Inc. | 1995-09-26 |
| K953556 | VACS TABLE, 9650 | U.S. Imaging Tables, Inc. | 1995-09-26 |
| K951176 | KOORDINAT M | Siemens Medical Solutions USA, Inc. | 1995-04-20 |
| K950981 | ULTRA-PRO ULTRASOUND SCANNING TABLE MODEL #056-650 | Biodex Medical Systems, Inc. | 1995-04-03 |
| K950402 | CORSINI 9090 | C.A.T. DI Corsini G. & C. Spa | 1995-03-31 |
| K945842 | MOBILIX MOBILE X-RAY TABLE | GE Medical Systems | 1995-01-18 |
Legacy Summary#
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FDA Review#
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