Table, Radiologic
FDA product code KXJ · Class II (moderate risk) · 21 CFR 892.1980 · Radiology
31510(k) clearances
0PMA approvals
27recalls
Manufacturers
- Siemens Corp. 3
- Continental X-Ray Corp. 2
- Philips Medical Systems (Cleveland) Inc 2
- Radkor, Inc. 2
- Combined Concepts, Inc. 1
- Villa Sistemi Medicali S.P.A. 1
- Philips Medical Systems North America, Inc. 1
- Nucletron-Oldelft Corp. 1
- Toshiba America Medical Systems, In.C 1
- Bay X-Ray, Inc. 1
- Imatron, Inc. 1
- Shimadzu Precision Instruments, Inc. 1
- General Electric Co. 1
- Smith & Nephew, Inc. 1
- Professional Medical Products, Inc. 1
- Richard D. Spradlin 1
- Tecnomed, Inc. 1
- Quinton, Inc. 1
- Pausch Corp. 1
- General Electrical Espanola, S.A. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K050190 | ApolloKXJ · Abbreviated | Villa Sistemi Medicali S.P.A. | 03/25/2005SE |
| K963905 | Radiographic Itt TableKXJ · Traditional | X-Ray Technologies, Inc. | 11/12/1996SE |
| K955414 | XRT 400KXJ · Traditional | Wuestec Medical, Inc. | 07/24/1996SE |
| K951146 | Imaging TableKXJ · Traditional | Septa Corp. | 05/04/1995SE |
| K950068 | Carbon Fiber Couch InsertKXJ · Traditional | Medtec, Inc. | 04/06/1995SE |
| K950442 | Infrared Exposure Hand SwitchKXJ · Traditional | Medical X-Ray Intl., Inc. | 03/31/1995SE |
| K940696 | Syncra Tilt Option for Angio Diagnost 5KXJ · Traditional | Philips Medical Systems North America, Inc. | 03/16/1994SE |
| K931724 | Electrophysiology (Ep) Table Ep 2000 SeriesKXJ · Traditional | Continental X-Ray Corp. | 06/14/1993SE |
| K926407 | Model Cole TAB-2 Table W/Model Cole SFD-2 SpotfilmKXJ · Traditional | Nucletron-Oldelft Corp. | 03/31/1993SE |
| K922098 | CAG-02AKXJ · Traditional | Toshiba America Medical Systems, In.C | 07/27/1992SE |
| K913121 | Omniflex Overhead Tubecrane CAT.#S-9108/#6713.400KXJ · Traditional | Continental X-Ray Corp. | 08/16/1991SE |
| K883885 | Radkor, RF-159KXJ · Traditional | Radkor, Inc. | 10/19/1988SE |
| K883155 | Rastix X-Ray TableKXJ · Traditional | Bay X-Ray, Inc. | 09/06/1988SE |
| K881700 | Radkor KOB-84KXJ · Traditional | Radkor, Inc. | 09/02/1988SE |
| K874934 | Universal Examination TableKXJ · Traditional | Imatron, Inc. | 01/19/1988SE |
| K874639 | Remote-Controlled Universal Diag. Table RS-100KXJ · Traditional | Shimadzu Precision Instruments, Inc. | 12/04/1987SE |
| K871827 | Omega III Angiographic Table, Rotation & StepperKXJ · Traditional | General Electric Co. | 06/19/1987SE |
| K862144 | X-MatKXJ · Traditional | Combined Concepts, Inc. | 06/25/1986SE |
| K860620 | Shampaine Radi-Op Model 1700RCKXJ · Traditional | Smith & Nephew, Inc. | 04/08/1986SE |
| K854328 | Medex X-Ray TableKXJ · Traditional | Philips Medical Systems (Cleveland), Inc. | 01/28/1986SE |
| K834478 | Chick/Reison Patient Emerg. TrolleyKXJ · Traditional | Professional Medical Products, Inc. | 02/21/1984SE |
| K820111 | Siemens Sireskop 4KXJ · Traditional | Siemens Corp. | 02/18/1982SE |
| K812791 | Portable Medical TableKXJ · Traditional | Richard D. Spradlin | 11/24/1981SE |
| K811969 | Dual Pedestal TableKXJ · Traditional | Philips Medical Systems (Cleveland), Inc. | 08/13/1981SE |
| K811196 | Allmec 90/15KXJ · Traditional | Tecnomed, Inc. | 06/09/1981SE |
| K803120 | Tilting Imaging Table #846TKXJ · Traditional | Quinton, Inc. | 01/22/1981SE |
| K790783 | Koordinat 3DKXJ · Traditional | Siemens Corp. | 05/07/1979SE |
| K790743 | Coordinatus, Horizontal RadiographocKXJ · Traditional | Pausch Corp. | 04/23/1979SE |
| K790692 | TelevixKXJ · Traditional | General Electrical Espanola, S.A. | 04/23/1979SE |
| K790536 | ClearviewKXJ · Traditional | Hipoint Research, Inc. | 03/28/1979SE |
| K781992 | Koordinat AngioKXJ · Traditional | Siemens Corp. | 12/07/1978SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-3034-2026 Class II | ORT300, operating room table, ORT300 Modular Table Main Unit Assy Part Numbers…The linear actuator and rotational lock mechanism components may experience a mechanical failure that… | IMRIS Imaging Inc | 08/06/2026Open, Classified |
| Z-1420-2025 Class II | Baxter TruSystem 7500 Hybrid Plus (SC), Product Code 1854088There is a software issue which causes the upper back section to not be operable/adjustable when the… | Baxter Healthcare Corporation | 02/25/2025Open, Classified |
| Z-1416-2025 Class II | Baxter TruSystem 7500 Hybrid (MC), Product Code 1773204There is a software issue which causes the upper back section to not be operable/adjustable when the… | Baxter Healthcare Corporation | 02/25/2025Open, Classified |
| Z-1415-2025 Class II | Baxter Floor mounting column TS 7500 U, Product Code 1730732There is a software issue which causes the upper back section to not be operable/adjustable when the… | Baxter Healthcare Corporation | 02/25/2025Open, Classified |
| Z-1414-2025 Class II | Baxter Stationary column TruSystem 7500 U, Product Code 1730731There is a software issue which causes the upper back section to not be operable/adjustable when the… | Baxter Healthcare Corporation | 02/25/2025Open, Classified |
| Z-1413-2025 Class II | Baxter Mobile column TruSystem 7500 U, Product Code 1730720There is a software issue which causes the upper back section to not be operable/adjustable when the… | Baxter Healthcare Corporation | 02/25/2025Open, Classified |
| Z-2586-2021 Class II | Operating room table - Product Usage: intended for use during diagnostic examinations…ORT200/300 rotational lock may fail to function such that it cannot change states between locked and… | Deerfield Imaging, Inc. | 08/25/2021Terminated |
| Z-2585-2021 Class II | Operating room table - Product Usage: intended for use during diagnostic examinations…ORT200/300 rotational lock may fail to function such that it cannot change states between locked and… | Deerfield Imaging, Inc. | 08/25/2021Terminated |
| Z-2584-2021 Class II | Operating room table - Product Usage: intended for use during diagnostic examinations…ORT200/300 rotational lock may fail to function such that it cannot change states between locked and… | Deerfield Imaging, Inc. | 08/25/2021Terminated |
| Z-0766-2020 Class II | Apollo EZ, Model Number 9784152036 - Product Usage: The Apollo EZ remote-controlled…An amendment to the IFU and Service Manual is being issued to prescribe the replacement of the angulation… | Villa Sistemi Medicali S.P.A. | 11/04/2019Open, Classified |
| Z-0765-2020 Class II | Apollo DRF, Model Number 9784220831 - Product Usage: The remote controlled table Apollo…An amendment to the IFU and Service Manual is being issued to prescribe the replacement of the angulation… | Villa Sistemi Medicali S.P.A. | 11/04/2019Open, Classified |
| Z-0764-2020 Class II | Apollo, Model Numbers 9784100231, 9784120131, 9784130131 - Product Usage: Apollo table…An amendment to the IFU and Service Manual is being issued to prescribe the replacement of the angulation… | Villa Sistemi Medicali S.P.A. | 11/04/2019Open, Classified |
| Z-0763-2020 Class II | Juno DRF, Model Number 709020 - Product Usage: General. multi-function x-ray systems…An amendment to the IFU and Service Manual is being issued to prescribe the replacement of the angulation… | Villa Sistemi Medicali S.P.A. | 11/04/2019Open, Classified |
| Z-1753-2019 Class II | Prestilix 1600X Prestilix system is a fully integrated remote controlled digital…There has been a reported incident of a Distar CRT monitor that has fallen off the monitor wall mount… | GE Healthcare, LLC | 03/29/2019Terminated |
| Z-0975-2018 Class II | IMRIS ORT100 Table, Part Number 110470-000The rotational locking mechanisms on the ORT 100/ T2X tables can become disengaged or unlocked while in use… | Deerfield Imaging, Inc. | 02/20/2018Terminated |
| Z-1430-2017 Class II | Apollo EZ; Model: 9784152036 Product Usage: General, multi-function x-ray systems…Patient fell from the table because the footrest of the device detached from the table top while the patient… | Villa Sistemi Medicali S.P.A. | 12/27/2016Terminated |
| Z-1429-2017 Class II | Apollo DRF; Model: 9784220831 Product Usage: General, multi-function x-ray systems…Patient fell from the table because the footrest of the device detached from the table top while the patient… | Villa Sistemi Medicali S.P.A. | 12/27/2016Terminated |
| Z-1428-2017 Class II | Apollo; Models: 9784000131 9784000231 9784020131 9784020231 9784100231 9784120131…Patient fell from the table because the footrest of the device detached from the table top while the patient… | Villa Sistemi Medicali S.P.A. | 12/27/2016Terminated |
| Z-1427-2017 Class II | Juno DRF; Model: 709020 Product Usage: General, multi-function x-ray systems capable of…Patient fell from the table because the footrest of the device detached from the table top while the patient… | Villa Sistemi Medicali S.P.A. | 12/27/2016Terminated |
| Z-1066-2017 Class II | Apollo EZ: Model: 9784152036 Multi-function x-ray systems capable of routine radiograph…The analysis showed that the incident was caused by a chain of four faults: 1.) The injured person overcame… | Villa Radiology Systems LLC | 02/19/2016Open, Classified |
| Z-1065-2017 Class II | Apollo DRF: Model: 9784220831 Multi-function x-ray systems capable of routine radiograph…The analysis showed that the incident was caused by a chain of four faults: 1.) The injured person overcame… | Villa Radiology Systems LLC | 02/19/2016Open, Classified |
| Z-1064-2017 Class II | Apollo: Models: 9784000131, 9784000231, 9784020131, 9784020231, 9784100231, 9784120131…The analysis showed that the incident was caused by a chain of four faults: 1.) The injured person overcame… | Villa Radiology Systems LLC | 02/19/2016Open, Classified |
| Z-1063-2017 Class II | Juno DRF; Model: 709020 Multi-function x-ray systems capable of routine radiograph and…The analysis showed that the incident was caused by a chain of four faults: 1.) The injured person overcame… | Villa Radiology Systems LLC | 02/19/2016Open, Classified |
| Z-1079-2015 Class II | Juno DFR X-ray systemThe system does not provide the appropriate audible signal, permanent activation, and manual override… | Villa Radiology Systems LLC | 12/14/2014Terminated |
| Z-2160-2013 Class II | Juno DRF System. Mobile X-ray system These are general, multi-function x-ray systems…It has been discovered that the Air Kerma rate information is inconsistent in Continuous Fluoro modes 30x30… | Villa Radiology Systems LLC | 08/02/2013Terminated |
| Z-2238-2011 | Maquet Magnus Carbon-fibre table top; Device Part Number 1180.16xx (x represents a digit…Maquet GmbH's quality monitoring detected that incorrect cover sheets were installed with some Magnus carbon… | Maquet Inc. | 04/15/2011Terminated |
| Z-0075-2008 | Sunisa Flexi-DT Table, Model Numbers: 51335678, 2269647, 2242088-2, 5141609-2, 5115763…Design Problems Including: 1) Hot Brake (Longitudinal Overheating) potential risk of burns 2) Brake Locks… | GE Healthcare | 08/01/2007Terminated |