Table, Radiographic, Non-Tilting, Powered
FDA product code IZZ · Class II (moderate risk) · 21 CFR 892.1980 · Radiology
29510(k) clearances
0PMA approvals
13recalls
Manufacturers
- General Electric Co. 3
- Shimadzu Medical Systems 3
- Continental X-Ray Corp. 3
- Toshiba America Medical Systems, In.C 2
- Warner-Lambert Co. 1
- Siemens Medical Solutions USA, Inc. 1
- Philips Medical Systems (Cleveland) Inc 1
- Raymax Medical Corp. 1
- Control-X, Inc. 1
- Biodan Medical Systems, Ltd. 1
- Imt America, Inc. 1
- Rms Div. 1
- Gendex Corp. 1
- Xre Corp. 1
- Mallinckrodt Group, Inc. 1
- Fischer Imaging Corp. 1
- D&R X-Ray Products, Inc. 1
- Alimed, Inc. 1
- Spectrum X-Ray Corp. 1
- Bennett X-Ray Corp. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K971452 | Multix Top/Pro Radiographic X-Ray TableIZZ · Traditional | Siemens Medical Solutions USA, Inc. | 05/14/1997SE |
| K952701 | Med-Tron SPECT Imaging TableIZZ · Traditional | Med-Tron Products, Inc. | 07/06/1995SE |
| K951315 | Catheterization Table KS-60IZZ · Traditional | Shimadzu Medical Systems | 05/11/1995SE |
| K951053 | Angiorex CAT-350BIZZ · Traditional | Toshiba America Medical Systems, In.C | 04/06/1995SE |
| K943926 | Rapido 2000 Automatic Radiographic TableIZZ · Traditional | Philips Medical Systems (Cleveland), Inc. | 11/28/1994SE |
| K930273 | AlphaIZZ · Traditional | Raymax Medical Corp. | 07/13/1993SE |
| K924444 | B-4 Four-Way Radiographic TableIZZ · Traditional | Control-X, Inc. | 02/05/1993SE |
| K925174 | Shimadzu Radiographic Table BK-100IZZ · Traditional | Shimadzu Medical Systems | 11/27/1992SE |
| K921501 | Deluxe C Arm Radiological Table, Model #056-004IZZ · Traditional | Biodan Medical Systems, Ltd. | 05/15/1992SE |
| K920732 | Catherization KS-50IZZ · Traditional | Shimadzu Medical Systems | 04/16/1992SE |
| K915413 | CAT-250BIZZ · Traditional | Toshiba America Medical Systems, In.C | 12/19/1991SE |
| K912516 | Classic-Ii 4-WAY Horizontal Table Cat.# T-9111IZZ · Traditional | Continental X-Ray Corp. | 11/19/1991SE |
| K912474 | Classic 4-WAY Elevating TableIZZ · Traditional | Continental X-Ray Corp. | 09/16/1991SE |
| K903921 | Mte-T Radiogrphic/Tomographic Elevating TableIZZ · Traditional | Imt America, Inc. | 12/04/1990SE |
| K896665 | EXT-600 Table, Radiographic, ElevatingIZZ · Traditional | Rms Div. | 01/22/1990SE |
| K894188 | Gx-ElevatorIZZ · Traditional | Gendex Corp. | 10/03/1989SE |
| K893452 | Extra Strength Effergrip Denture Adhesive CreamIZZ · Traditional | Warner-Lambert Co. | 06/22/1989SE |
| K891403 | Hugh Young II Urological TableIZZ · Traditional | Mallinckrodt Group, Inc. | 06/22/1989SE |
| K893129 | CXC FFT-1 Non-Tilt Stat Radio Xray Tab 4 Wa FL TabIZZ · Traditional | Continental X-Ray Corp. | 06/01/1989SE |
| K884930 | Compax Model 40, 400, 400TIZZ · Traditional | General Electric Co. | 12/22/1988SE |
| K883974 | Tangent IIIZZ · Traditional | Fischer Imaging Corp. | 10/20/1988SE |
| K861940 | Radiographic Tables Models A71OS-T,A71OT-T,A71OB-TIZZ · Traditional | D&R X-Ray Products, Inc. | 05/29/1986SE |
| K840156 | Protecta Coat SpongesIZZ · Traditional | Alimed, Inc. | 03/23/1984SE |
| K834494 | Spectrum X-Ray CorpIZZ · Traditional | Spectrum X-Ray Corp. | 02/21/1984SE |
| K827928 | VRT TableIZZ · Traditional | General Electric Co. | 09/29/1982SE |
| K792169 | Horizontal Radiographic 4/WAY FloatingIZZ · Traditional | Bennett X-Ray Corp. | 12/10/1979SE |
| K772283 | RX Pedestal TableIZZ · Traditional | General Electric Co. | 12/15/1977SE |
| K771601 | X-Ray Remote Control TableIZZ · Traditional | Toshiba Medical Systems | 09/20/1977SE |
| K761339 | Radial Travel Spec. Procedures TableIZZ · Traditional | Xre Corp. | 01/05/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2188-2024 Class II | ZE for Vertix Solitaire - The AXIOM Vertix Solitaire is a component and has been…Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire | Siemens Medical Solutions USA, Inc | 05/31/2024Open, Classified |
| Z-2187-2024 Class II | MULTIX TOP - Intended Use: The Multix TOP I PRO Radiographic X ray Table is a patient…Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire | Siemens Medical Solutions USA, Inc | 05/31/2024Open, Classified |
| Z-2186-2024 Class II | MULTIX TOP - Intended Use: The Multix TOP I PRO Radiographic X ray Table is a patient…Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire | Siemens Medical Solutions USA, Inc | 05/31/2024Open, Classified |
| Z-2185-2024 Class II | AXIOM Vertix Solitaire - The Vertix MD Trauma has been specially designed for examining…Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire | Siemens Medical Solutions USA, Inc | 05/31/2024Open, Classified |
| Z-2184-2024 Class II | AXIOM Vertix MD - The Vertix MD Trauma has been specially designed for examining…Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire | Siemens Medical Solutions USA, Inc | 05/31/2024Open, Classified |
| Z-2183-2024 Class II | AXIOM MULTIX MP - Inended Radiographic X ray Table is a patient table used in…Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire | Siemens Medical Solutions USA, Inc | 05/31/2024Open, Classified |
| Z-2182-2024 Class II | AXIOM MULTIX MP - Intended Radiographic X ray Table is a patient table used in…Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire | Siemens Medical Solutions USA, Inc | 05/31/2024Open, Classified |
| Z-2181-2024 Class II | AXIOM MULTIX MT - Intended Radiographic X ray Table is a patient table used in…Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire | Siemens Medical Solutions USA, Inc | 05/31/2024Open, Classified |
| Z-2180-2024 Class II | AXIOM MULTIX MT - Intended Radiographic X ray Table is a patient table used in…Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire | Siemens Medical Solutions USA, Inc | 05/31/2024Open, Classified |
| Z-1511-2022 Class II | Service manuals for the CT, PET, or NM table as follows: GT1700/GT1700V/VT1700…As a result of unclear guidance in the service manual, the table can drop during a specific service activity… | GE Healthcare, LLC | 06/02/2022Open, Classified |
| Z-0298-2019 Class II | AXIOM Multix MT (model number 8395415 or 8395399 or 8395381), a patient table used in…In rare cases of high clinical workload, the steel cables inside the lifting column of the overhead tube… | Siemens Medical Solutions USA, Inc | 08/06/2018Terminated |
| Z-1460-2014 Class II | AXIOM Vertix MD Trauma systems radiographic X-rayThere is a potential issue and possible hazard to patients when using the AXIOM Vertix MD Trauma systems. In… | Siemens Medical Solutions USA, Inc | 03/05/2014Terminated |
| Z-0457-2010 | GE Medical Systems, COMPAX 40E X-ray Systems, Models; 2208203, 2208205, 2244282…GE Healthcare has recently become aware that table lock safety features, which are provided with Compax 40E… | GE Medical Systems, LLC | 07/30/2009Terminated |