Table, Radiographic, Tilting
Regulation 892.1980
0510(k)s in 12 months (77 all time)
1recalls in 12 months (26 all time)
17recalls that name a 510(k)
Top companies in IXR
| Company | 510(k)s | Recalls |
|---|---|---|
| Fischer Imaging Corp. | 8 | 0 |
| Shimadzu Medical Systems | 7 | 1 |
| Philips Medical Systems North America Co. Phillips | 0 | 4 |
| U.S. Imaging Tables, Inc. | 4 | 0 |
| GE Healthcare | 0 | 3 |
| General Electric Co. | 3 | 0 |
| Medical Positioning Inc | 0 | 3 |
| Siemens Medical Solutions USA, Inc. | 3 | 0 |
| Spectrum X-Ray Corp. | 3 | 0 |
| Tri W-G, Inc. | 3 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 7, 2025 | Sonesta Medical AB Brand Name: Sonesta
Product Name: 6210
Model/Catalog Number: 0120-LA120-03
Software Version: N/A
Product Description: Sonesta 6210 - Procedure table designed for full fluoroscopic imaging of the urina Open, Classified |
IXR | None listed |
| Dec 30, 2019 | Philips North America, LLC UroDiagnost Eleva, system code 708033 Terminated |
IXR | K911098 |
| May 2, 2019 | Oakworks Inc OAKWORKS Inc.Lithotripsy/Urology Table: CFLU401, Catalog Number: 75216-T01 - Product Usage: Oakworks Imaging Tables are radiographic tables intended for use with mobile or compact stationary C-arm Ima Terminated |
IXR | None listed |
| Feb 28, 2019 | Philips North America, LLC Urodiagnost, Product No. 708033
Product Usage:
The Philips UroDiagnost MRF can be used to perform all urological and gynecological routine examinations including: Urograms with injection or infusio Terminated |
IXR | K911098 |
| May 3, 2018 | Philips Medical Systems Nederlands 708033 URODiagnost
As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiography and Angiography can be Performed along with more specialized interventional applica Terminated |
IXR | K911098 |
| Feb 23, 2018 | Oakworks Inc Foot Controls impacted for the following devices:
OAKWORKS Medical CFPM 300 Imaging Table
OAKWORKS Medical CFPM 301 Imaging Table
OAKWORKS Medical CFPM 400 Imaging Table
OAKWORKS Medical CFPM 401 Ima Terminated |
IXR | None listed |
| May 22, 2017 | GE Healthcare, LLC Table Patient Step on RFX/SFX, Legacy, and Precision 500D systems Terminated |
IXR | K011624 K081091 +4 |
| Feb 27, 2017 | LIEBEL-FLARSHEIM COMPANY LLC Liebel-Flarsheim Hydra Vision Urology X-Ray System (DR)
Liebel-Flarsheim urology systems facilitate radiologic and/or fluoroscopic procedures requiring a beam of diagnostic quality radiation, prima Terminated |
IXR | K943581 |
| Nov 21, 2016 | GE Healthcare, LLC RFX Terminated |
IXR | K760466 |
| Jul 19, 2016 | Philips Electronics North America Corporation UroDiagnost; x-ray system. Product Code: 708033 Terminated |
IXR | K911098 |
| Apr 28, 2016 | Shimadzu Medical Systems X-Ray Diagnostic Table, Model No. YSF-300
Use in combination with an X-ray high voltage generator, an X-ray tube unit, an Image intensifier and X-ray television unit, this table is applied for the fol Terminated |
IXR | None listed |
| Aug 15, 2012 | Philips Healthcare Inc. Philips Easy Diagnost Classic-Stationary x-ray system
Catalog Numbers: 70642, 70643, 706030, 706031, 706032
Stationary x-ray system, Universal RF system for general use. Terminated |
IXR | K031535 K970640 |
| Jun 18, 2012 | Philips Healthcare Inc. Philips Easy Diagnost
Product Usage: Stationary Fluoroscopic system Terminated |
IXR | K031535 K970640 |
| Apr 13, 2011 | Medical Positioning Inc Rapid Response HUT (Head Up Tilt) Table. Model 1217. Powered electrophysiology tilt table with dual 2 way drop section. Table that can tilt -15 degree to 90 degree (Trendelenburg). Medical Positioni Terminated |
IXR | None listed |
| Apr 13, 2011 | Medical Positioning Inc Rapid Response HUT (Head Up Tilt) Table. Model 1117. Powered electrophysiology tilt table with single drop section. Table that can tilt -15 degrees to 90 degrees (Trendelenburg). Medical Positioning Terminated |
IXR | None listed |
| Apr 13, 2011 | Medical Positioning Inc Rapid Response H.U.T. (Head Up Tilt) Table. Model 1017. Powered electrophysiology tilt table. Table can tilt -15 degrees to 90 degrees (Trendelenburg). Medical Positioning Incorporated.800-593-3246. Terminated |
IXR | None listed |
| Mar 16, 2011 | Toshiba American Medical Systems Inc Toshiba DUA-450F Kalare Radiographic Tilting Table. Terminated |
IXR | K922364 |
| Sep 13, 2010 | Philips Medical Systems North America Co. Phillips Easy Diagnost DSI is a Easy Diagnost Digital Spot Imaging system. It has a capability to create digital images from an analog system.
Intended use is for the following applications: as a multifunct Terminated |
IXR | K023440 K920793 |
| Sep 13, 2010 | Philips Medical Systems North America Co. Phillips EasyDiagnost Classic has a radiographic tilting table. This system has a cassette film option and it does not have a Digital Spot Imaging (DSI) system.
Intended use is for the following applications Terminated |
IXR | K970640 |
| Mar 23, 2010 | Philips Medical Systems North America Co. Phillips EasyDiagnost. Multi-functional R/F systems used for general R/F, Fluoroscopy, Radiography and Angiography examinations. Terminated |
IXR | K970640 |
| Oct 20, 2008 | Stille AB Sonesta 6210 Fluoroscopy Procedure Table; a motorized procedure table with adjustments (via a remote control) for height, tilt, back and seat cushion position; Stille Surgical AB, Sundbybergsvagen 1A, Terminated |
IXR | None listed |
| Sep 19, 2008 | GE Healthcare Advantx Legacy Radiographic and Fluoroscopic systems, model 2102424, 2118104, 2157009, 2183000, 2206038, 2206048, 2206056, 2224559, 2258627, 2268730, 2330340, 2333974, 2118104-2, 2118104-3, 2118104-4, Terminated |
IXR | K973039 |
| Sep 25, 2007 | Philips Medical Systems North America Co. Phillips Philips Easy Diagnost X-Ray System Terminated |
IXR | K970640 |
| Feb 15, 2007 | Stille-Sonesta, Inc Stille Sonesta Video Fluoroscopy Table 6210; manufactured by Stille AB, Solna, Sweden. Terminated |
IXR | None listed |
| Feb 24, 2005 | General Electric Med Systems LLC Patient tables of CT systems with brand name: CT/e; CT/e Dual; CT/e Plus, CT/e Dual Plus; CT/e Lite; ProSpeed AI; ProSpeed AII; ProSpeed FI; ProSpeed FII; ProSpeed EII; CT HiSpeed Series. Terminated |
IXR | K021491 K944013 +3 |
| Jan 30, 2003 | Siemens Medical Systems Inc Uroskop D1/D2/D3 - Table, Radiographic, Stationary Top. Terminated |
IXR | K923049 |
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