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)
Sep 25, 2018Swissray Medical
ddR Formula B X-ray System, ddR Formula B Product Usage: X-ray system used for imaging
Open, Classified
KPRK052943
Sep 18, 2018Swissray Medical
ddR Formula B X-ray System, Model ddR Formula B X-ray system used for imaging
Open, Classified
KPRK052943
Aug 6, 2018Siemens Medical Solutions USA, Inc
Ysio MAX (model number 10762470) with Tube stand 3D V (model number 7042018 or 7042034), radiographic systems used in radiographic and tomographic exposures of the whole body.
Terminated
KPRK133259
Aug 6, 2018Siemens Medical Solutions USA, Inc
Ysio (model number 10281013 or 10281163) with Tube stand 3D V (model number 7042018 or 7042034), radiographic systems used for radiographic and tomographic exposures of the whole body.
Terminated
KPRK081722
Aug 3, 2018Siemens Medical Solutions USA, Inc
Multix Fusion system is a radiographic system: Models: Multix Fusion Analog (model number 10746665) with Tube stand 3D V (model number 7042042 or 7042059); Multix Fusion Digital Portable (model number
Terminated
KPRK121513
Jul 16, 2018GE Healthcare, LLC
Brivo XR385, model 5215463, Digital Diagnostic Radiographic System
Terminated
KPRK103448
May 3, 2018Philips Medical Systems Nederlands
MultiDiagnostic-Eleva with Flat Detector 708035 As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiography and Angiography can be Performed along with more speci
Terminated
KPRK050151
May 3, 2018Philips Medical Systems Nederlands
MultiDiagnostic-Eleva with Flat Detector 708038 As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiography and Angiography can be Performed along with more speci
Terminated
KPRK050151
May 3, 2018Philips Medical Systems Nederlands
Mutlidiagnost-Eleva with Flat Detector Eleva with Flat Detector 708037 As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiography and Angiography can be Perform
Terminated
KPRK050151
May 3, 2018Philips Medical Systems Nederlands
Mutlidiagnost-Eleva with Flat Detector 708034 As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiography and Angiography can be Performed along with more special
Terminated
KPRK050151
May 3, 2018Philips Medical Systems Nederlands
MultiDim Eleva 708032 As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiography and Angiography can be Performed along with more specialized interventional ap
Terminated
KPRK050151
Apr 5, 2018Visaris DOO
Visaris Vision/Auto, ddRAura OTC APS, Diagnostic X-Ray System, Version 2.4 The Vision systems are intended for use in all areas of diagnostic radiography imaging and specifically at secondary and ter
Terminated
KPRK160620
Apr 5, 2018Visaris DOO
Visaris Vision/Auto, ddRAura OTC APS, Diagnostic X-Ray System, Version 2.3 The Vision systems are intended for use in all areas of diagnostic radiography imaging and specifically at secondary and tert
Terminated
KPRK160620
Apr 5, 2018Visaris DOO
Visaris Vision/Auto, ddRAura OTC APS, Diagnostic X-Ray System, Version 2.2 The Vision systems are intended for use in all areas of diagnostic radiography imaging and specifically at secondary and ter
Terminated
KPRK160620
Jul 14, 2017Philips Electronics North America Corporation
Mobile Detector Holder - Stationary X-ray System (RF System). suitable for positioning the wireless portable detector free in the room for X-ray exposures. It supports the wireless portable detector w
Terminated
KPRK031535
Jun 22, 2017NeuroLogica Corporation
The GC80 Digital X-ray Imaging System
Terminated
KPRK143029
Jun 15, 2017Fujifilm Medical Systems U.S.A., Inc.
FUJIFILM FDR Visionary Suite with CH-200. Model # CH-200, Catalog: Visionary Suite (FMSU Marketing Name) The FDR Visionary Suite is intended to generate digital or conventional radiographic images of
Terminated
KPRK152294
May 31, 2017Philips Electronics North America Corporation
Philips DuraDiagnost X-ray systems: DuraDiagnost (R1.0, Product Number 712210) DuraDiagnost (R2.0, Product Number 712211) DuraDiagnost (R3.0, Product Number 712211)
Terminated
KPRK141381
May 24, 2017NeuroLogica Corporation
Samsung GU60A system- Digital X-ray Imaging Systems are intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended fo
Terminated
KPRNone listed
May 23, 2017Shimadzu Medical Systems Usa Com
SHIMADZU FDR Visionary Catalog Number: FDR Visionary Suite Stationary x-ray system for taking general radiographic and tomographic images of the whole body. The device is intended to be used in hos
Terminated
KPRK152294
May 23, 2017Shimadzu Medical Systems Usa Com
SHIMADZU RADspeed Pro Catalog Number: RADspeed Pro; Stationary x-ray system
Terminated
KPRK152244
May 23, 2017Shimadzu Medical Systems Usa Com
SHIMADZU Ceiling Type X-ray Tube Support CH-200/CH-200M Catalog Number: CH-200/CH-200M Holds an x-ray tube unit and collimator combined with an z-ray high voltage generator, radiographic stand, and t
Terminated
KPRNone listed
Apr 5, 2017AGFA Healthcare Corp.
DX-D600 - DXD Imaging Package
Terminated
KPRK112670
Nov 18, 2016Philips Medical Systems (Cleveland) Inc
FV-RF (Clinix RF Plus) Product Usage: A Stationary X-ray System, a device intended for radiographic/fluoroscopic examinations of various anatomical regions. This device may include signal analysis an
Terminated
KPRK984111
Sep 1, 2016Philips Electronics North America Corporation
Philips DuraDiagnost stationary X-ray system
Terminated
KPRK141381
Aug 1, 2016Siemens Medical Solutions USA, Inc
YSIO Max Product Usage: The Ysio Max is a radiographic system used in hospitals, clinics, and medical practices. Ysio Max enables radiographic and tomographic exposures of the whole body including:
Terminated
KPRK133259
Aug 1, 2016Siemens Medical Solutions USA, Inc
Multix Fusion VA10 Product Usage: The Multix Fusion VA10 system is a radiographic system used in hospitals, clinics, and medical practices. Multix Fusion enables radiographic exposures of the whole b
Terminated
KPRK121513
Aug 1, 2016Siemens Medical Solutions USA, Inc
Multix Fusion Stationary X-Ray System Product Usage: The Multix Fusion system is a radiographic system used in hospitals, clinics, and medical practices. Multix Fusion enables radiographic exposures
Terminated
KPRK121513
Jun 3, 2016Philips Healthcare
Philips Healthcare DuraDiagnost stationary X-ray system
Terminated
KPRK141381
Aug 22, 2015Carestream Health Inc
CARESTREAM DRX-EVOLUTION X-Ray System Product Usage: The device is a permanently installed diagnostic X-ray system for general radiographic x-ray imaging including tomography. The tomography feature
Terminated
KPRK141837
Jul 22, 2015Philips Electronics North America Corporation
Philips Healthcare TraumaDiagnost; Codes: 72001, 720011, 720013, 720020; A radiological examination unit for emergency work and routine skeletal diagnosis.
Terminated
KPRK945278
May 23, 2015Siemens Medical Solutions USA, Inc
SIEMENS Ysio Max; a radiographic system used in hospitals, clinics, and medical practices. Ysio Max enables radiographic and tomographic exposures of the whole body including: skull, chest, abdomen,
Terminated
KPRK133259
May 19, 2015Philips Medical Systems, Inc.
Philips Healthcare DuraDiagnost X- Ray
Terminated
KPRK141381
May 5, 2015Siemens Medical Solutions USA, Inc
AXIOM ARISTOS FX; Multipurpose Radiography System (MPRS) is a dedicated x-ray system with a flat panel detector which allows the acquisition of x-ray exposures without the use of conventional film/scr
Terminated
KPRK013826
Mar 6, 2015GE Healthcare
GE Healthcare Proteus XR/a with wall stand model number 2260354. Intended for use in generating radiographic images of human anatomy in all general purpose diagnostic procedures. This device is not i
Terminated
KPRK993090
Mar 6, 2015Philips Medical Systems, Inc.
Philips DuraDiagnost X-Ray system, Stationary X-Ray System Radiographic Models: 712210, 712211
Terminated
KPRK141381
Jan 16, 2015Siemens Medical Solutions USA, Inc
Ysio Max, Luminos dRF Max and Agile Max systems with software version VE10 and SmartOrtho license. The Ysio Max is a radiographic system used in hospitals, clinics, and medical practices. Ysio Max en
Terminated
KPRK062623
K111292 +1
Jan 12, 2015GE Healthcare
GE Healthcare, Proteus XR/a with wall stand model number 600-0301.
Terminated
KPRK993090
Oct 2, 2014Siemens Medical Solutions USA, Inc
Siemens Luminos Agile Max system The Luminos Agile is intended to be used as a universal imaging system for radiographic and fluoroscopic studies. Using either film cassettes or a digital mobile flat
Terminated
KPRK111292
Oct 2, 2014Siemens Medical Solutions USA, Inc
Siemens Uroskop Omnia Max system The Uroskop Omnia is a solid state detector fluoroscopic X-Ray system, primarily for urological applications (functional x-ray diagnostic, endourology and minimal inv
Terminated
KPRK101491
Oct 2, 2014Siemens Medical Solutions USA, Inc
Siemens AXIOM Luminos dRF Max systems The Axiom Luminos dRF is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies. Using a digital flat detector,
Terminated
KPRK062623
Oct 2, 2014Siemens Medical Solutions USA, Inc
Siemens Ysio Max system The Ysio Max is a radiographic system used in hospitals, clinics, and medical practices. Ysio Max enables radiographic and tomographic exposures of the whole body including: sk
Terminated
KPRK133259
Sep 24, 2014Philips Medical Systems, Inc.
Foot Switches used with Philips MultiDiagnost Eleva with Flat Detector; Product Codes: 708037, 708038 This Philips MultiDiagnost Eleva is intended to be used as a multifunctional/universal system. Gen
Terminated
KPRK050151
Sep 23, 2014Siemens Medical Solutions USA, Inc
The Ysio Systems with software version VC10 The Ysio enables radiographic and tomographic exposures of the whole Body including: skull, chest, abdomen, and extremities and may be used on pediatric, a
Terminated
KPRK081722
Aug 19, 2014Philips Medical Systems, Inc.
Patient Support Material Number: 9890 010 87431, used with:EasyDiagnost ; Model: 706050
Terminated
KPRK031535
Aug 19, 2014Philips Medical Systems, Inc.
Patient Support Material Number: 9890 010 87431 used with: BuckyDiagnost ; Model: 704060/706037
Terminated
KPRK945278
Aug 10, 2014AGFA Healthcare Corp.
DX-D 600 - DXD Imaging Package Product Usage:Is indicated for use in providing diagnostic quality images to aid the physician with diagnosis. Systems can be used with MUSICA2 image processing to crea
Terminated
KPRK112670
Aug 10, 2014Carestream Health, Inc.
Kodak DirectView DR 7500 Diagnostic X-Ray System Product Usage: The DR 7500 system is a permanently installed diagnostic x-ray system composed of 4 main components: an operator console, over head t
Terminated
KPRK051258
Aug 1, 2014Carestream Health Inc.
KODAK DirectView DR 9000 System, Catalog Numbers 1966688 (US and Canada) and 8161937 (outside the US and Canada) --- A permanently installed diagnostic x-ray system composed of 3 main components: an
Terminated
KPRNone listed
Jul 2, 2014GE Healthcare, LLC
GE Healthcare, Revolution XR/d. Revolution XR/d Intended Use: The Revolution XR/d Digital Radiographic imaging system is indicated for use in generating radiographic images of human anatomy. It is i
Terminated
KPRK012389

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