ClearanceBrief
Panels › Radiology › Product code JAA · Class 2

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)
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Top companies in JAA

DateFirm and productCodeLinked 510(k)
Jun 10, 2019GE 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
JAAK011624
K081091
Jun 10, 2019GE Healthcare, LLC
Prestige II, Prestige SI, Prestige VH Prestige system is a new multi-purpose conventional and digital R/F remote controlled system.
Terminated
JAAK943805
Mar 12, 2019Philips North America, LLC
Azurion FlexArm, 722079
Terminated
JAAK181830
Feb 28, 2019Philips 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
JAAK982993
Feb 8, 2019Siemens 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
JAAK101491
Nov 7, 2018Philips Medical Systems Gmbh, DMC
Stationary Fluoroscopic X-ray System CombiDiagnost R90, Model 709030 Stationary Fluoroscopic X-ray System
Terminated
JAAK163210
Jun 27, 2018Philips Medical Systems Nederlands
OmniDiagnost-Eleva X-ray system Angiographic and Diagnostic, Product Nos. 708026, 708027, 708028
Terminated
JAAK032046
May 25, 2018Siemens 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
JAAK021021
Mar 20, 2018Siemens 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
JAAK021021
Dec 29, 2017Toshiba American Medical Systems Inc
INFX-8000H Fluoroscopic X-Ray Systems
Terminated
JAAK082830
Oct 19, 2017Philips 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
JAAK163210
Sep 12, 2017Toshiba 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
JAAK133553
Mar 14, 2017Hans 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
JAAK161019
Nov 21, 2016GE Healthcare, LLC
SFX
Terminated
JAAK801320
Nov 21, 2016GE Healthcare, LLC
Prestige VH
Terminated
JAAK943805
Nov 21, 2016GE Healthcare, LLC
Prestige SI
Terminated
JAAK943805
Nov 21, 2016GE Healthcare, LLC
Prestige II
Terminated
JAAK943805
Nov 21, 2016GE Healthcare, LLC
Precision 500D
Terminated
JAAK081091
Nov 21, 2016GE Healthcare, LLC
Legacy
Terminated
JAAK862120
Nov 20, 2016Shimadzu Medical Systems
Shimadzu X-ray TV System, Catalog No. SONIALVISION G4
Terminated
JAAK142341
May 19, 2016Toshiba American Medical Systems Inc
Toshiba Ultimax DREX-ULT80 X-ray generator
Terminated
JAANone listed
May 19, 2016Toshiba American Medical Systems Inc
Toshiba Kalare DREX-KL80 X-ray generator
Terminated
JAANone listed
Apr 15, 2016Ziehm Imaging Inc
Ziehm Vision2, Mobile C-arm for Mobile Fluoroscopic Imaging
Terminated
JAAK073346
Apr 15, 2016Ziehm Imaging Inc
Ziehm Vision RFD Mot, Mobile C-arm for Mobile Fluoroscopic Imaging
Terminated
JAAK132904
Mar 21, 2016Toshiba 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
JAAK133553
Feb 19, 2016Siemens 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
JAAK021021
Sep 30, 2015Shimadzu Medical Systems
Shimadzu C-arm Table, Catalog No. IVS-110, Medical Imaging Table.
Terminated
JAAK963888
Jul 20, 2015GE Healthcare
GE Healthcare, Precision MPi fluoroscopic imaging systems.
Terminated
JAAK033486
Jul 20, 2015GE Healthcare
GE Healthcare Precision 500D Classical R & F system.
Terminated
JAAK081091
Jul 2, 2015GE 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
JAAK081091
K973039
May 23, 2015Siemens 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
JAAK101491
May 23, 2015Siemens 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
JAAK111292
Oct 2, 2014GE 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
JAAK081091
Sep 10, 2014Siemens 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
JAAK062623
K081722 +1
Jan 21, 2014GE 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
JAAK011624
K081091 +4
Nov 27, 2013Siemens 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
JAAK062623
K101491
Oct 17, 2013GE 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
JAAK011624
K081091 +3
Aug 20, 2013GE Healthcare, LLC
GE Healthcare, Precision 500D Product Usage: The Precision 500D is designed to perform radiographic and fluoroscopic x-ray examinations.
Terminated
JAAK011624
Jul 10, 2013Toshiba American Medical Systems Inc
TOSHIBA Kalare Diagnostic X-Ray System K110785
Terminated
JAAK110785
May 17, 2013Hologic, 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
JAAK051025
May 17, 2013Hologic, 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
JAAK051025
Apr 11, 2013Siemens 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
JAAK992660
Sep 25, 2012Hologic, 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
JAAK051025
Sep 25, 2012Hologic, 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
JAAK051025
Sep 10, 2012Siemens Medical Solutions USA, Inc
Siemens Uroskop Access. Fluoroscopic, image intensified x-ray system
Terminated
JAAK010942
Aug 22, 2012GE 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
JAAK021049
K022069 +1
Aug 17, 2012GE 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
JAAK003837
Aug 1, 2012GE 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
JAAK993687
Jul 24, 2012GE 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
JAAK021049
K022069 +1
Jul 18, 2012GE 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
JAAK021049
K022069 +1

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