System, X-Ray, Stationary
Regulation 892.1680
7510(k)s in 12 months (359 all time)
3recalls in 12 months (170 all time)
160recalls that name a 510(k)
Top companies in KPR
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 2, 2014 | GE Healthcare, LLC GE Healthcare, Proteus XR/a.
Proteus XR/a Intended Use: Is intended for use in generating radiographic images of human anatomy in all general purpose diagnostic procedures. This device is not intende Terminated |
KPR | K993090 |
| Jun 21, 2014 | Siemens Medical Solutions USA, Inc Siemens RAD Fluoro Uro System (Ysio, Luminos dRF, and Uroskop Omnia) with software versions VB10G.
Product Usage: Image Intensified Fluoroscopic X-ray system Terminated |
KPR | K062623 K081722 +1 |
| Jun 4, 2014 | Siemens Medical Solutions USA, Inc Siemens Ysio Systems
Product Usage: The Ysio (New RAD-FAMILY) systems are radiographic systems used in hospitals, clinics, and medical practices. Ysio enables radiographic and tomographic exposures Terminated |
KPR | K081722 |
| Apr 24, 2014 | Siemens Medical Solutions USA, Inc MULTIX FUSION.
The Multix Fusion system is a radiographic system used in hospitals, clinics, and medical practices. Multix Fusion enables radiographic exposures of the whole body including: skull, ch Terminated |
KPR | K121513 |
| Jan 29, 2014 | Carestream Health Inc. Carestream DRX Evolution System (Standard Q)
The DRX-Evolution System (Standard Q) is a permanently installed diagnostic x-ray system for generation of x-rays for examination of various anatomical re Terminated |
KPR | None listed |
| Jan 27, 2014 | Carestream Health, Inc. KODAK DirectView DR 7500 Dual Detector System, MODEL DR 7500, Manufactured by Carestream Health, Inc. Made in U.S.A. Terminated |
KPR | K051258 |
| Dec 2, 2013 | Philips Medical Systems, Inc. Easy Diagnost Eleva
Universal Fluoroscopic applications Terminated |
KPR | K031535 |
| Nov 26, 2013 | Siemens Medical Solutions USA, Inc (Siemens Rad Fluoro Uro Systems) Ysio, Luminos Agile, Luminos dRF, and Uroskop Omnia systems with software version VC10
Image intensified fluoroscopic x-ray system Terminated |
KPR | K062623 K081722 +2 |
| Aug 26, 2013 | Philips Healthcare Inc. Philips Easy Upgrade DR, Code No: 712086
This system is used for making X-Ray exposures for diagnostics. Terminated |
KPR | K982795 |
| Aug 12, 2013 | Carestream Health Inc. Carestream DRX Evolution System, X-Ray System ---
The DRX-Evolution system is a permanently installed diagnostic x-ray system for generation of x-rays for examination of various anatomical regions. Terminated |
KPR | K091889 |
| Jun 17, 2013 | Philips Healthcare Inc. Philips BuckyDiagnost Radiographic.
Catalog Numbers:
704031, 704032, 704035, 704060, 704062
This system is used for making x-ray exposures for diagnostics Terminated |
KPR | K945278 |
| Jun 17, 2013 | Philips Healthcare Inc. Philips BuckyDiagnost Radiographic, a Diagnostic X-ray system.
Catalog Numbers:
704031, 704032, 704035, 704060, 704062
This system is used for making x-ray exposures for diagnostics. Terminated |
KPR | K945278 |
| Feb 1, 2013 | Philips Healthcare Inc. Phillips Easy Diagnost Eleva DRF. Model Number: 706034
Product Usage:
Universal Fluoroscopic Applications Terminated |
KPR | K031535 |
| Aug 15, 2012 | Philips Healthcare Inc. Philips Essenta DR, X-Ray System, Diagnostic, general-purpose
Model: 712070.
The Essenta DR is a multifunctional stationary X-ray Intended Use From Labeling): system, in which the swivel arm rotation Terminated |
KPR | K070528 |
| Aug 8, 2012 | Philips Healthcare Inc. Philips MultiDiagnost Eleva with Flat Detector (MD Eleva FD)Model: 708034
Product Usage:
Philips X-ray System Terminated |
KPR | K050151 |
| Jun 8, 2012 | General Electric Med Systems LLC GE Proteus XR/a Radiographic System. GE Medical Systems-Americas Milwaukee, WI.
Model Number: 2259988.
Product is indicated for use in generating radiographic images of human anatomy in all general- Terminated |
KPR | K993090 |
| Mar 27, 2012 | Philips Healthcare Inc. Philips Healthcare EasyDiagnost Eleva DRF 4.0
Stationary X-Ray System with DRF as an option for digital radiography. Terminated |
KPR | None listed |
| Mar 15, 2012 | Philips Healthcare Inc. Philips EasyDiagnost Eleva DRF, Fluoroscopic x-ray system
Software Release 3.0 and 3.1
Model: 706034
Product Usage: Radiological image processing system (computed radiography x-ray system) Terminated |
KPR | K031535 |
| Feb 21, 2012 | GE Healthcare, LLC REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM WITH TOMOSYNTHESIS
The Revolution XR/d with Tomosynthesis is intended for use in generating Tomographic images of human anatomy. It is not intended Terminated |
KPR | K051967 |
| Jan 11, 2012 | GE Healthcare, LLC GE Healthcare Discovery XR650, Digital Radiographic Systems.
Revolution XR/d Digital Radiographic Imaging System with Image Pasting and Autopositioning is indicated for use in generating radiographi Terminated |
KPR | K050704 |
| Jan 11, 2012 | GE Healthcare, LLC GE Healthcare Definium 8000, Digital Radiographic Systems.
Revolution XR/d Digital Radiographic Imaging System with Image Pasting and Autopositioning is indicated for use in generating radiographic Terminated |
KPR | K050704 |
| Apr 12, 2011 | Siemens Medical Solutions USA, Inc Axiom Aristos FX and FX Plus System
Intended use: Stationary x-ray system Terminated |
KPR | K013826 K061054 |
| Nov 26, 2010 | Philips Medical Systems North America Co. Phillips Product's marketing brochure is labeled in part: "Philips Easy Diagnost Eleva Conventional R/F system...PHILIPS". manufactured by Philips Medical Systems Gmbh, Hamburg, Germany. Terminated |
KPR | K031535 |
| Oct 7, 2010 | Philips Medical Systems North America Co. Phillips The BABIX holder is an accessory used with the DigitalDiagnost X-ray system. It is used to hold the baby either in a secured or immobilized standing position in front of the X-ray detector during th Terminated |
KPR | K982795 |
| Oct 7, 2010 | Philips Medical Systems North America Co. Phillips The BABIX holder is an accessory used with the BuckyDiagnost X-ray system. It is used to hold the baby either in a secured or immobilized standing position in front of the X-ray detector during the e Terminated |
KPR | K945278 |
| Oct 6, 2010 | Philips Medical Systems North America Co. Phillips Essenta DR is a digital multifunctional X-ray systems, suitable for all routine radiographic exams, including specialist areas like trauma or pediatric work, excluding mammography.
It is designed for Terminated |
KPR | K070528 |
| Sep 14, 2010 | Philips Medical Systems North America Co. Phillips DigitalDiagnost X-ray System is a stationary Diagnostic X-ray using Digital Solid State Imaging Detector. It is identified with Part Number 4512 201 04752 Software Version 1.5.1 and Part Number 4512 Terminated |
KPR | K982795 |
| Aug 10, 2010 | Philips Medical Systems North America Co. Phillips The Philips EasyDiagnost Eleva with DRF. Philips Medical Systems multifunctional x-ray system. Terminated |
KPR | K031535 K063781 |
| Mar 23, 2010 | Philips Medical Systems North America Co. Phillips BuckyDiagnost. General Radiography and Tomography examination of patients in supine, seated, or standing positions. Terminated |
KPR | K945278 |
| Dec 16, 2009 | GE Medical Systems, LLC GE Healthcare Definium 8000.Model # 5131070.
GE Healthcare, 3000 North Grandview, Waukesha, WI 53188.
The Revolution XR/d with Tomosynthesis is intended for use in generating Tomographic Images of hu Terminated |
KPR | K051967 |
| Dec 16, 2009 | GE Medical Systems, LLC GE Healthcare Revolution XR/d. Model #'s 2259988-2 & 2351505.
GE Healthcare, 3000 North Grandview, Waukesha, WI 53188.
The Revolution XR/d Digital Radiographic Imaging System is indicated for use in Terminated |
KPR | K012389 |
| Dec 16, 2009 | GE Medical Systems, LLC GE Healthcare Proteus XR/a. Model # 2259988.
GE Healthcare, 3000 North Grandview, Waukesha, WI 53188.
The Silhouette FC is indicated for use in generating radiographic images of human anatomy in all Terminated |
KPR | K993090 |
| Sep 25, 2009 | GE Healthcare, LLC Definium 5000 X-ray System, model number 5220493 and 5220393-2 Terminated |
KPR | K063283 |
| Sep 25, 2009 | Philips Medical Systems North America Co. Phillips Philips Medical Systems MultiDiagnost Eleva Flat Detector System with software version 4.3.1 or higher
Used for general R/F, fluoroscopy, radiography, and angiography examinations. Terminated |
KPR | K050151 |
| Sep 24, 2009 | GE Medical Systems, LLC Revolution XR/d system control room PC model 5117866-2 with Software collector 5115434 Terminated |
KPR | K051967 |
| Sep 22, 2009 | GE Medical Systems, LLC Revolution XR/d systems with control room PC model 5117866-2 with Software collector 5194381. GE Healthcare, 3000 North Grandview, Waukesha, WI 53188.
Intended for use in generating Tomographic image Terminated |
KPR | K051967 |
| Oct 20, 2008 | Siemens Medical Solutions USA, Inc Axiom Aristos FX Multipurpose Radiography System, stationary X-Ray system, Model number: 7414803. Terminated |
KPR | K013826 |
| Sep 30, 2008 | GE Healthcare GE Healthcare Proteus XR/a Eclipse Collimator model # 2379827. Terminated |
KPR | K993090 |
| Sep 25, 2008 | GE Healthcare GE Healthcare Definium 8000 Digital Radiographic System. Formerly GE Healthcare Revolution XR/d with Tomosynthesis. Terminated |
KPR | K051967 |
| Sep 25, 2008 | GE Healthcare GE Healthcare Definium 8000 Digital Radiographic System. Terminated |
KPR | K051967 |
| Sep 25, 2008 | GE Healthcare GE Healthcare Definium 8000 Digital Radiographic System, model number 5135678. GE Healthcare, 3000 North Grandview, Waukesha, WI 53188 U.S.A.
The intended use of this product is to generate tomograp Terminated |
KPR | K051967 |
| Sep 16, 2008 | Philips Medical Systems North America Co. Phillips Essenta DR - digital multifunctional x-ray system (application SW release 1.0.2 and lower). The device is intended for routine exams, including specialist areas like trauma or pediatric work, excludi Terminated |
KPR | K070528 |
| Sep 4, 2008 | GE Healthcare GE Healthcare Definium 5000 Digital Radiographic Imaging System. Model number 5220493-2.
The Definium 5000 System is designed to handle radiographic applications using the digital system. The system Terminated |
KPR | K063283 |
| Sep 4, 2008 | GE Healthcare GE Healthcare Definium 5000 Digital Radiographic Imaging System. Model numbers 5220493.
The Definium 5000 System is designed to handle radiographic applications using the digital system. The system c Terminated |
KPR | K063283 |
| Jun 10, 2008 | GE Healthcare GE Healthcare Proteus XR/a Radiographic X-ray System, Model Number 2259976; previously marketed as the Silhouette FC, GE Healthcare, Waukesha, WI 53188. Terminated |
KPR | K993090 |
| Feb 23, 2008 | Carestream Health, Inc. Kodak DirectView Model DR 3000 System, Stationary X-ray System; Catalog #s 6551360, 6551386, 6552152, 6552160, 6551345, 6552319, 6552335. The units are labeled under the following firms: EASTMAN KODAK Terminated |
KPR | K060550 |
| Sep 25, 2007 | Philips Medical Systems North America Co. Phillips Philips Easy Diagnost Eleva Terminated |
KPR | K031535 |
| Sep 25, 2007 | Philips Medical Systems North America Co. Phillips Philips Bucky DIagnost X-Ray System Terminated |
KPR | K945278 |
| Sep 25, 2007 | General Electric Med Systems LLC GE Healthcare Proteus XR/a General Purpose Radiographic System, Models 2259973-4 and 2380179 containing Proteus Operator Console model# 2259976. Terminated |
KPR | K993090 |
| Jul 3, 2007 | Carestream Health, Inc. Kodak Direct View DR3000 System, Stationary X-ray System, Catalog #s 655-1345, 655-1386. Terminated |
KPR | K060550 |
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