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) |
|---|---|---|---|
| Sep 25, 2018 | Swissray Medical ddR Formula B X-ray System, ddR Formula B
Product Usage:
X-ray system used for imaging Open, Classified |
KPR | K052943 |
| Sep 18, 2018 | Swissray Medical ddR Formula B X-ray System, Model ddR Formula B
X-ray system used for imaging Open, Classified |
KPR | K052943 |
| Aug 6, 2018 | Siemens 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 |
KPR | K133259 |
| Aug 6, 2018 | Siemens 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 |
KPR | K081722 |
| Aug 3, 2018 | Siemens 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 |
KPR | K121513 |
| Jul 16, 2018 | GE Healthcare, LLC Brivo XR385, model 5215463, Digital Diagnostic Radiographic System Terminated |
KPR | K103448 |
| May 3, 2018 | Philips 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 |
KPR | K050151 |
| May 3, 2018 | Philips 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 |
KPR | K050151 |
| May 3, 2018 | Philips 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 |
KPR | K050151 |
| May 3, 2018 | Philips 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 |
KPR | K050151 |
| May 3, 2018 | Philips 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 |
KPR | K050151 |
| Apr 5, 2018 | Visaris 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 |
KPR | K160620 |
| Apr 5, 2018 | Visaris 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 |
KPR | K160620 |
| Apr 5, 2018 | Visaris 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 |
KPR | K160620 |
| Jul 14, 2017 | Philips 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 |
KPR | K031535 |
| Jun 22, 2017 | NeuroLogica Corporation The GC80 Digital X-ray Imaging System Terminated |
KPR | K143029 |
| Jun 15, 2017 | Fujifilm 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 |
KPR | K152294 |
| May 31, 2017 | Philips 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 |
KPR | K141381 |
| May 24, 2017 | NeuroLogica 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 |
KPR | None listed |
| May 23, 2017 | Shimadzu 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 |
KPR | K152294 |
| May 23, 2017 | Shimadzu Medical Systems Usa Com SHIMADZU RADspeed Pro Catalog Number: RADspeed Pro;
Stationary x-ray system Terminated |
KPR | K152244 |
| May 23, 2017 | Shimadzu 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 |
KPR | None listed |
| Apr 5, 2017 | AGFA Healthcare Corp. DX-D600 - DXD Imaging Package Terminated |
KPR | K112670 |
| Nov 18, 2016 | Philips 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 |
KPR | K984111 |
| Sep 1, 2016 | Philips Electronics North America Corporation Philips DuraDiagnost stationary X-ray system Terminated |
KPR | K141381 |
| Aug 1, 2016 | Siemens 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 |
KPR | K133259 |
| Aug 1, 2016 | Siemens 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 |
KPR | K121513 |
| Aug 1, 2016 | Siemens 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 |
KPR | K121513 |
| Jun 3, 2016 | Philips Healthcare Philips Healthcare DuraDiagnost stationary X-ray system Terminated |
KPR | K141381 |
| Aug 22, 2015 | Carestream 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 |
KPR | K141837 |
| Jul 22, 2015 | Philips Electronics North America Corporation Philips Healthcare TraumaDiagnost; Codes: 72001, 720011, 720013, 720020; A radiological examination unit for emergency work and routine skeletal diagnosis. Terminated |
KPR | K945278 |
| May 23, 2015 | Siemens 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 |
KPR | K133259 |
| May 19, 2015 | Philips Medical Systems, Inc. Philips Healthcare DuraDiagnost X- Ray Terminated |
KPR | K141381 |
| May 5, 2015 | Siemens 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 |
KPR | K013826 |
| Mar 6, 2015 | GE 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 |
KPR | K993090 |
| Mar 6, 2015 | Philips Medical Systems, Inc. Philips DuraDiagnost X-Ray system, Stationary X-Ray System Radiographic
Models: 712210, 712211 Terminated |
KPR | K141381 |
| Jan 16, 2015 | Siemens 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 |
KPR | K062623 K111292 +1 |
| Jan 12, 2015 | GE Healthcare GE Healthcare, Proteus XR/a with wall stand model number 600-0301. Terminated |
KPR | K993090 |
| Oct 2, 2014 | Siemens 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 |
KPR | K111292 |
| Oct 2, 2014 | Siemens 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 |
KPR | K101491 |
| Oct 2, 2014 | Siemens 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 |
KPR | K062623 |
| Oct 2, 2014 | Siemens 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 |
KPR | K133259 |
| Sep 24, 2014 | Philips 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 |
KPR | K050151 |
| Sep 23, 2014 | Siemens 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 |
KPR | K081722 |
| Aug 19, 2014 | Philips Medical Systems, Inc. Patient Support Material Number: 9890 010 87431, used with:EasyDiagnost ; Model: 706050 Terminated |
KPR | K031535 |
| Aug 19, 2014 | Philips Medical Systems, Inc. Patient Support Material Number: 9890 010 87431 used with: BuckyDiagnost ; Model: 704060/706037 Terminated |
KPR | K945278 |
| Aug 10, 2014 | AGFA 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 |
KPR | K112670 |
| Aug 10, 2014 | Carestream 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 |
KPR | K051258 |
| Aug 1, 2014 | Carestream 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 |
KPR | None listed |
| Jul 2, 2014 | GE 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 |
KPR | K012389 |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.