System, X-Ray, Fluoroscopic, Image-Intensified
Regulation 892.1650
1510(k)s in 12 months (300 all time)
1recalls in 12 months (223 all time)
197recalls that name a 510(k)
Top companies in JAA
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 10, 2019 | GE Healthcare, LLC Precision 500D
The Precision 500D R&F X-ray System is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic examinations, including general R&F and pediatric Terminated |
JAA | K011624 K081091 |
| Jun 10, 2019 | GE Healthcare, LLC Prestige II, Prestige SI, Prestige VH
Prestige system is a new multi-purpose conventional and digital R/F remote controlled system. Terminated |
JAA | K943805 |
| Mar 12, 2019 | Philips North America, LLC Azurion FlexArm, 722079 Terminated |
JAA | K181830 |
| Feb 28, 2019 | Philips North America, LLC Omnidiagnost Classic, Product Codes 70859, 708023, 708024, 708025
Product Usage:
The Philips OmniDiagnost is a multi-functional, universal X-ray system with remote-controlled facilities. It performs Terminated |
JAA | K982993 |
| Feb 8, 2019 | Siemens Medical Solutions USA, Inc Uroskop Omnia -fluoroscopic X-ray system
Model # 10094910
The Uroskop Omnia is a solid state detector fluoroscopic X-ray system, primarily for urological applications (functional x-ray diagnosis, end Terminated |
JAA | K101491 |
| Nov 7, 2018 | Philips Medical Systems Gmbh, DMC Stationary Fluoroscopic X-ray System CombiDiagnost R90, Model 709030
Stationary Fluoroscopic X-ray System Terminated |
JAA | K163210 |
| Jun 27, 2018 | Philips Medical Systems Nederlands OmniDiagnost-Eleva X-ray system Angiographic and Diagnostic, Product Nos. 708026, 708027, 708028 Terminated |
JAA | K032046 |
| May 25, 2018 | Siemens Medical Solutions USA, Inc AXIOM Artis with Laird Cooling Unit for SSFD: Material # 7555118. Artis is an angiography system developed for single and biplane diagnostic imaging and interventional procedures. Terminated |
JAA | K021021 |
| Mar 20, 2018 | Siemens Medical Solutions USA, Inc AXIOM Artis angiographic x-ray system, Model Numbers: 7412807, 7413078, 7728392
AXIOM Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and inter Terminated |
JAA | K021021 |
| Dec 29, 2017 | Toshiba American Medical Systems Inc INFX-8000H Fluoroscopic X-Ray Systems Terminated |
JAA | K082830 |
| Oct 19, 2017 | Philips Electronics North America Corporation CombiDiagnost R90 Image-Intensified fluoroscopic x-ray system
CombiDiagnost R90 is a multi-functional general R/F system. It is suitable for all routine radiography and fluoroscopy exams, including s Terminated |
JAA | K163210 |
| Sep 12, 2017 | Toshiba American Medical Systems Inc Toshiba Medical Kalare Fluoroscopic X-Ray System (DREX-KL80)
Kalare is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic examinations, including gene Terminated |
JAA | K133553 |
| Mar 14, 2017 | Hans Pausch Rontgengeratebau Gmbh Pausch Uroview FD fluoroscopic X-ray system
UDI number (01)04260491620040
Primarily for urological applications (functional X-ray diagnostics, endourology and minimal invasive urology / surgery). Th Terminated |
JAA | K161019 |
| Nov 21, 2016 | GE Healthcare, LLC SFX Terminated |
JAA | K801320 |
| Nov 21, 2016 | GE Healthcare, LLC Prestige VH Terminated |
JAA | K943805 |
| Nov 21, 2016 | GE Healthcare, LLC Prestige SI Terminated |
JAA | K943805 |
| Nov 21, 2016 | GE Healthcare, LLC Prestige II Terminated |
JAA | K943805 |
| Nov 21, 2016 | GE Healthcare, LLC Precision 500D Terminated |
JAA | K081091 |
| Nov 21, 2016 | GE Healthcare, LLC Legacy Terminated |
JAA | K862120 |
| Nov 20, 2016 | Shimadzu Medical Systems Shimadzu X-ray TV System, Catalog No. SONIALVISION G4 Terminated |
JAA | K142341 |
| May 19, 2016 | Toshiba American Medical Systems Inc Toshiba Ultimax DREX-ULT80 X-ray generator Terminated |
JAA | None listed |
| May 19, 2016 | Toshiba American Medical Systems Inc Toshiba Kalare DREX-KL80 X-ray generator Terminated |
JAA | None listed |
| Apr 15, 2016 | Ziehm Imaging Inc Ziehm Vision2, Mobile C-arm for Mobile Fluoroscopic Imaging Terminated |
JAA | K073346 |
| Apr 15, 2016 | Ziehm Imaging Inc Ziehm Vision RFD Mot, Mobile C-arm for Mobile Fluoroscopic Imaging Terminated |
JAA | K132904 |
| Mar 21, 2016 | Toshiba American Medical Systems Inc Toshiba DRAD-3000E FPD Wireless System
Product Usage The DRAD-3000 is intended for use with the ceiling-suspended tube support, high voltage generator, and bucky stand or bucky table incorporating Terminated |
JAA | K133553 |
| Feb 19, 2016 | Siemens Medical Solutions USA, Inc AXIOM Artis (system, x-ray, angiographic) for single and biplane diagnostic imaging and interventional procedures such as cardiac and neuro angiography, general and rotational angiography, operating r Terminated |
JAA | K021021 |
| Sep 30, 2015 | Shimadzu Medical Systems Shimadzu C-arm Table, Catalog No. IVS-110, Medical Imaging Table. Terminated |
JAA | K963888 |
| Jul 20, 2015 | GE Healthcare GE Healthcare, Precision MPi fluoroscopic imaging systems. Terminated |
JAA | K033486 |
| Jul 20, 2015 | GE Healthcare GE Healthcare Precision 500D Classical R & F system. Terminated |
JAA | K081091 |
| Jul 2, 2015 | GE Healthcare GE Healthcare Precision 500D and Advantx Legacy/Legacy-D Radiographic and Fluoroscopic Systems.
A universal diagnostic imaging system for radiographic and fluoroscopic examinations. Applications can Terminated |
JAA | K081091 K973039 |
| May 23, 2015 | Siemens Medical Solutions USA, Inc SIEMENS Uroskop Omnia Max ; a solid state detector fluoroscopic X-Ray system, primarily for urological applications (functional x-ray diagnostic, endourology and minimal invasive urology/surgery). The Terminated |
JAA | K101491 |
| May 23, 2015 | Siemens Medical Solutions USA, Inc SIEMENS Luminos Agile Max; a universal imaging system for radiographic and fluoroscopic studies. Using either film cassettes or a digital mobile flat detector, it can perform a range of applications i Terminated |
JAA | K111292 |
| Oct 2, 2014 | GE Healthcare, LLC GE Healthcare Precision 500D, Classical R&F System.
Product Usage:
The Precision 500D R&F X-ray System is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopi Terminated |
JAA | K081091 |
| Sep 10, 2014 | Siemens Medical Solutions USA, Inc Siemens Luminos dRF, Ysio or Uroskop Omnia systems.
The Axiom Luminos dRF is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies. Terminated |
JAA | K062623 K081722 +1 |
| Jan 21, 2014 | GE Healthcare, LLC Video Monitor Suspensions that may be on the following Fluoroscopic and Radiographic X-Ray systems: Precision 500D, Legacy, Prestilix, Monitrol, RFX, SFX, Tilt-C, Prestige VH, Prestige SI, and Presti Terminated |
JAA | K011624 K081091 +4 |
| Nov 27, 2013 | Siemens Medical Solutions USA, Inc Siemens RAD Fluoro Uro system (Luminos dRF and Uroskop Omnia with software version VD10A/G
Image intensified Fluoroscopic X-ray system Terminated |
JAA | K062623 K101491 |
| Oct 17, 2013 | GE Healthcare, LLC GE Healthcare, Precision 500D, Legacy, RFX, and SFX X.
This table is intended for use in a diagnostic X-ray system to support patients during general purpose radiological procedures in the horizonta Terminated |
JAA | K011624 K081091 +3 |
| Aug 20, 2013 | GE Healthcare, LLC GE Healthcare, Precision 500D
Product Usage:
The Precision 500D is designed to perform radiographic and fluoroscopic x-ray examinations. Terminated |
JAA | K011624 |
| Jul 10, 2013 | Toshiba American Medical Systems Inc TOSHIBA Kalare Diagnostic X-Ray System
K110785 Terminated |
JAA | K110785 |
| May 17, 2013 | Hologic, Inc. Fluoroscan Mini C-arm InSight2, software versions 3.x, 4.0, 4.0.1, 4.0.2
The device is a Mini C-arm Fluroscopic Imaging System designed to provide physicians with general fluoroscopic visualization o Terminated |
JAA | K051025 |
| May 17, 2013 | Hologic, Inc. Fluoroscan Mini C-arm InSight, software versions 1.x, 2.x, 3.x
The device is a Mini C-arm Fluroscopic Imaging System designed to provide physicians with general fluoroscopic visualization of a patien Terminated |
JAA | K051025 |
| Apr 11, 2013 | Siemens Medical Solutions USA, Inc Iconos R200 C20, Iconos R200 T20, Iconos R100, Iconos MD, Iconos RHD, Luminos RF Classic, Luminos Fusion or Luminos Select.
Angiographic x-ray system. Terminated |
JAA | K992660 |
| Sep 25, 2012 | Hologic, Inc. Hologic Fluoroscan Mini C-Arm Model with InSight- FD Software Version 5.0.1and 5.0.2
The device is a Mini C-arm Fluoroscopic Imaging System designed to provide -physicians with general fluoroscopic v Terminated |
JAA | K051025 |
| Sep 25, 2012 | Hologic, Inc. Hologic Fluoroscan Mini C-Arm Model with InSight2, Software version 4.0 and 4.0.1
The device is a Mini C-arm Fluoroscopic Imaging System designed to provide -physicians with general fluoroscopic vis Terminated |
JAA | K051025 |
| Sep 10, 2012 | Siemens Medical Solutions USA, Inc Siemens Uroskop Access.
Fluoroscopic, image intensified x-ray system Terminated |
JAA | K010942 |
| Aug 22, 2012 | GE OEC Medical Systems, Inc 892.1650 Image-intensified fluoroscopic x-ray system; the device is designed to provide fluoroscopic and spot film imaging of the patient during diagnostic surgical and interventional procedures. The Terminated |
JAA | K021049 K022069 +1 |
| Aug 17, 2012 | GE OEC Medical Systems, Inc GEHC OEC 8800 Mobile Fluoroscopic X-ray System, GE Healthcare, Surgery, Salt Lake City, UT.
Mobile fluoroscopic examination of human anatomy. Terminated |
JAA | K003837 |
| Aug 1, 2012 | GE OEC Medical Systems, Inc UroView 2800; MDL number A349855.
Product Usage: Designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical, and interventional procedures. Clinical applicatio Terminated |
JAA | K993687 |
| Jul 24, 2012 | GE OEC Medical Systems, Inc OEC 9800; OEC FluoroTrak 9800 Plus; OEC 9800 Plus; OEC 9800 MD Motorized C-arm System, 892.1650 Image-intensified fluoroscopic x-ray system.
The OEC 9800 is designed to provide fluoroscopic and spot- Terminated |
JAA | K021049 K022069 +1 |
| Jul 18, 2012 | GE OEC Medical Systems, Inc OEC 9800, OEC FluoroTrak 9800 Plus, OEC 9800 Plus, OEC 9800 MD Motorized C-arm System designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and intervention Terminated |
JAA | K021049 K022069 +1 |
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