Table, Radiographic, Stationary Top
FDA product code IXQ · Class II (moderate risk) · 21 CFR 892.1980 · Radiology
27510(k) clearances
0PMA approvals
7recalls
Manufacturers
- Medtec, Inc. 2
- Garrels X-Ray Products, Inc. 2
- Tecnomed, Inc. 2
- Continental X-Ray Corp. 2
- Atomic Products Corp. 2
- Hofmann X-Ray of America, Inc. 1
- Wuestec Medical, Inc. 1
- Octostop, Inc. 1
- Image Diagnostics, Inc. 1
- Dial-A-Rad 1
- R-Made, Inc. 1
- Shimadzu Medical Systems 1
- Ssi Medical Services, Inc. 1
- Radkor, Inc. 1
- Radiological Engineering, Inc. 1
- Altairex Manufacturing, Inc. 1
- X-Ray Systems 1
- X-Ray Mfg. & Sales, Inc. 1
- Summit Industries, Inc. 1
- Carolina X-Ray Co., Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K973842 | Carbon Fiber Conformal Couch TopIXQ · Traditional | Medtec, Inc. | 12/05/1997SE |
| K960083 | Movable Cantilevered Radiographic Table XRT 100, 200 & 300IXQ · Traditional | Wuestec Medical, Inc. | 07/24/1996SE |
| K954225 | Med-Tec Hand GripIXQ · Traditional | Medtec, Inc. | 11/14/1995SE |
| K946262 | Euro, SCST, Sccft Atlas Radiologic TablesIXQ · Traditional | Scott Imaging Intl., Inc. | 02/15/1995SE |
| K942916 | Octopaque UniversalIXQ · Traditional | Octostop, Inc. | 09/08/1994SE |
| K942190 | ID100 Mobile Fluoroscopic Examining TableIXQ · Traditional | Image Diagnostics, Inc. | 08/17/1994SE |
| K913425 | Dial-A-Rad Porta Rad TableIXQ · Traditional | Dial-A-Rad | 11/24/1992SE |
| K923775 | R-Made Head/Arm SupportIXQ · Traditional | R-Made, Inc. | 10/20/1992SE |
| K920729 | Bucky Table BK-12IXQ · Traditional | Shimadzu Medical Systems | 04/27/1992SE |
| K914351 | Clinitron C-10IXQ · Traditional | Ssi Medical Services, Inc. | 02/14/1992SE |
| K912382 | Military Radiographic Flat Table, Cat # T-9130IXQ · Traditional | Continental X-Ray Corp. | 10/10/1991SE |
| K904187 | Economy C-Arm Table, Model # 056-005IXQ · Traditional | Atomic Products Corp. | 11/29/1990SE |
| K904623 | Radiographic Transport, Trauma Model 056-230, 235IXQ · Traditional | Atomic Products Corp. | 11/06/1990SE |
| K903160 | Liebel-Flarsheim Series 8000 Bucky,W/Non Size SensIXQ · Traditional | Continental X-Ray Corp. | 08/08/1990SE |
| K893690 | Super Speed Potter-Bucky (ESO5-110 & 220)IXQ · Traditional | Hofmann X-Ray of America, Inc. | 07/20/1989SE |
| K892196 | Radkor TS10-BIXQ · Traditional | Radkor, Inc. | 04/26/1989SE |
| K873702 | REI-38 Radiographic TableIXQ · Traditional | Radiological Engineering, Inc. | 04/22/1988SE |
| K873849 | Altairex Bucky/Cassette Tray CombinationIXQ · Traditional | Altairex Manufacturing, Inc. | 10/28/1987SE |
| K862825 | Hi-Lo Elevator Flat TableIXQ · Traditional | Garrels X-Ray Products, Inc. | 09/04/1986SE |
| K862826 | Itt Intergrated Table and TubestandIXQ · Traditional | Garrels X-Ray Products, Inc. | 08/01/1986SE |
| K855052 | Table Radiographic FixedIXQ · Traditional | X-Ray Systems | 02/06/1986SE |
| K842094 | Xmc-S Tubestand Xmt-S Table Xmh-NtwallIXQ · Traditional | X-Ray Mfg. & Sales, Inc. | 05/24/1985SE |
| K850118 | Xma Integrated TableIXQ · Traditional | Summit Industries, Inc. | 04/09/1985SE |
| K842614 | Carolina X-Ray Co. Simplafloat TableIXQ · Traditional | Carolina X-Ray Co., Inc. | 08/08/1984SE |
| K781681 | Phipiological Synchronizer PART#205IXQ · Traditional | Brattle Instrument Corp. | 10/17/1978SE |
| K781067 | Plurix B; Radiographic TableIXQ · Traditional | Tecnomed, Inc. | 07/17/1978SE |
| K781066 | Plurix C; Radiographic TableIXQ · Traditional | Tecnomed, Inc. | 07/17/1978SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-3021-2011 | CIVCO SBRT System, REF MTSBRT001L, containing CIVCO Pro-Lok Platform, REF MTSBRT002.…Systems sold before December 2009 displayed a scale of 0-40cm going from left to right, while systems after… | Civco Medical Instruments Inc | 12/30/2010Terminated |
| Z-3020-2011 | CIVCO SBRT System, REF MTSBRT001, containing CIVCO Pro-Lok Platform, REF MTSBRT002. Firm…Systems sold before December 2009 displayed a scale of 0-40cm going from left to right, while systems after… | Civco Medical Instruments Inc | 12/30/2010Terminated |
| Z-3019-2011 | CIVCO Pro-Lok Platform, REF MTSBRT002. Firm name on label is CIVCO, Orange City, Iowa…Systems sold before December 2009 displayed a scale of 0-40cm going from left to right, while systems after… | Civco Medical Instruments Inc | 12/30/2010Terminated |
| Z-0396-2011 | CIVCO Posifix Extension, REF MTIL6606, Reusable non-sterile extension for use with the…Under certain conditions, the extensions can become detached from the main body of the couch. | Med Tec Inc | 06/21/2010Terminated |
| Z-0395-2011 | CIVCO Type-S Extension, REF MTIL6605, Reusable non-sterile extension for use with…Under certain conditions, the extensions can become detached from the main body of the couch. | Med Tec Inc | 06/21/2010Terminated |
| Z-0394-2011 | CIVCO Rectangular Extension, REF MTIL6600, Reusable non-sterile extension for use with…Under certain conditions, the extensions can become detached from the main body of the couch. | Med Tec Inc | 06/21/2010Terminated |
| Z-1721-2009 | Foot Lok Cusion, Part Number MTAFS01, reusable nonsterile (20.3 x 42 x 25.4cm) cushion.The silkscreened indexing scale was reversed. | Med Tec Inc | 03/06/2009Terminated |