ClearanceBrief
Panels › Radiology › Product code KPR · Class 2

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)
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Top companies in KPR

DateFirm and productCodeLinked 510(k)
Jul 2, 2014GE 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
KPRK993090
Jun 21, 2014Siemens 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
KPRK062623
K081722 +1
Jun 4, 2014Siemens 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
KPRK081722
Apr 24, 2014Siemens 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
KPRK121513
Jan 29, 2014Carestream 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
KPRNone listed
Jan 27, 2014Carestream Health, Inc.
KODAK DirectView DR 7500 Dual Detector System, MODEL DR 7500, Manufactured by Carestream Health, Inc. Made in U.S.A.
Terminated
KPRK051258
Dec 2, 2013Philips Medical Systems, Inc.
Easy Diagnost Eleva Universal Fluoroscopic applications
Terminated
KPRK031535
Nov 26, 2013Siemens 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
KPRK062623
K081722 +2
Aug 26, 2013Philips Healthcare Inc.
Philips Easy Upgrade DR, Code No: 712086 This system is used for making X-Ray exposures for diagnostics.
Terminated
KPRK982795
Aug 12, 2013Carestream 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
KPRK091889
Jun 17, 2013Philips Healthcare Inc.
Philips BuckyDiagnost Radiographic. Catalog Numbers: 704031, 704032, 704035, 704060, 704062 This system is used for making x-ray exposures for diagnostics
Terminated
KPRK945278
Jun 17, 2013Philips 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
KPRK945278
Feb 1, 2013Philips Healthcare Inc.
Phillips Easy Diagnost Eleva DRF. Model Number: 706034 Product Usage: Universal Fluoroscopic Applications
Terminated
KPRK031535
Aug 15, 2012Philips 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
KPRK070528
Aug 8, 2012Philips Healthcare Inc.
Philips MultiDiagnost Eleva with Flat Detector (MD Eleva FD)Model: 708034 Product Usage: Philips X-ray System
Terminated
KPRK050151
Jun 8, 2012General 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
KPRK993090
Mar 27, 2012Philips Healthcare Inc.
Philips Healthcare EasyDiagnost Eleva DRF 4.0 Stationary X-Ray System with DRF as an option for digital radiography.
Terminated
KPRNone listed
Mar 15, 2012Philips 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
KPRK031535
Feb 21, 2012GE 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
KPRK051967
Jan 11, 2012GE 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
KPRK050704
Jan 11, 2012GE 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
KPRK050704
Apr 12, 2011Siemens Medical Solutions USA, Inc
Axiom Aristos FX and FX Plus System Intended use: Stationary x-ray system
Terminated
KPRK013826
K061054
Nov 26, 2010Philips 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
KPRK031535
Oct 7, 2010Philips 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
KPRK982795
Oct 7, 2010Philips 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
KPRK945278
Oct 6, 2010Philips 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
KPRK070528
Sep 14, 2010Philips 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
KPRK982795
Aug 10, 2010Philips Medical Systems North America Co. Phillips
The Philips EasyDiagnost Eleva with DRF. Philips Medical Systems multifunctional x-ray system.
Terminated
KPRK031535
K063781
Mar 23, 2010Philips Medical Systems North America Co. Phillips
BuckyDiagnost. General Radiography and Tomography examination of patients in supine, seated, or standing positions.
Terminated
KPRK945278
Dec 16, 2009GE 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
KPRK051967
Dec 16, 2009GE 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
KPRK012389
Dec 16, 2009GE 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
KPRK993090
Sep 25, 2009GE Healthcare, LLC
Definium 5000 X-ray System, model number 5220493 and 5220393-2
Terminated
KPRK063283
Sep 25, 2009Philips 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
KPRK050151
Sep 24, 2009GE Medical Systems, LLC
Revolution XR/d system control room PC model 5117866-2 with Software collector 5115434
Terminated
KPRK051967
Sep 22, 2009GE 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
KPRK051967
Oct 20, 2008Siemens Medical Solutions USA, Inc
Axiom Aristos FX Multipurpose Radiography System, stationary X-Ray system, Model number: 7414803.
Terminated
KPRK013826
Sep 30, 2008GE Healthcare
GE Healthcare Proteus XR/a Eclipse Collimator model # 2379827.
Terminated
KPRK993090
Sep 25, 2008GE Healthcare
GE Healthcare Definium 8000 Digital Radiographic System. Formerly GE Healthcare Revolution XR/d with Tomosynthesis.
Terminated
KPRK051967
Sep 25, 2008GE Healthcare
GE Healthcare Definium 8000 Digital Radiographic System.
Terminated
KPRK051967
Sep 25, 2008GE 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
KPRK051967
Sep 16, 2008Philips 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
KPRK070528
Sep 4, 2008GE 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
KPRK063283
Sep 4, 2008GE 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
KPRK063283
Jun 10, 2008GE 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
KPRK993090
Feb 23, 2008Carestream 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
KPRK060550
Sep 25, 2007Philips Medical Systems North America Co. Phillips
Philips Easy Diagnost Eleva
Terminated
KPRK031535
Sep 25, 2007Philips Medical Systems North America Co. Phillips
Philips Bucky DIagnost X-Ray System
Terminated
KPRK945278
Sep 25, 2007General 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
KPRK993090
Jul 3, 2007Carestream Health, Inc.
Kodak Direct View DR3000 System, Stationary X-ray System, Catalog #s 655-1345, 655-1386.
Terminated
KPRK060550

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