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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)
Feb 5, 2026FUJIFILM Healthcare Americas Corporation
FDR Visionary Suite; Model Number: CH-200; Version: (1) 566-16130-23, (2) 566-16130-31, (3)
Open, Classified
KPRK152294
Nov 7, 2025Philips Medical Systems DMC GmbH
Radiography 7300 C; Model Number: 712037;
Open, Classified
KPRK233662
Nov 7, 2025Philips Medical Systems DMC GmbH
DigitalDiagnost 4 (1) High Performance, (2) Flex/Value; Model Number: (1) 712031, (2) 712032;
Open, Classified
KPRK210692
Oct 7, 2025FUJIFILM Healthcare Americas Corporation
FDR Visionary Suite, CH-200 Model/Version Numbers: (1) 566-16130-23, (2) 566-16130-31, (3) 566-16130-33
Open, Classified
KPRK152294
Apr 11, 2025Philips North America Llc
Philips DXR System, DuraDiagnost Rel. 4. Stationary X-Ray System.
Open, Classified
KPRK141381
K201640
Apr 11, 2025Philips North America Llc
Philips DXR System, DuraDiagnost 4.1. Stationary X-Ray System.
Open, Classified
KPRK141381
K201640
Feb 3, 2025GE Medical Systems, LLC
Optima XR646 HD. X-Ray imaging system.
Open, Classified
KPRK173612
Feb 3, 2025GE Medical Systems, LLC
Discovery XR656 HD. X-Ray imaging system.
Open, Classified
KPRK172869
Feb 3, 2025GE Medical Systems, LLC
Discovery XR656HD. X-Ray imaging system.
Open, Classified
KPRK191699
Feb 3, 2025GE Medical Systems, LLC
Definium 656HD & Discovery XR656HD (GTINs: 00840682138598, 00195278840226, 00840682136709). X-Ray imaging system.
Open, Classified
KPRK231892
Nov 25, 2024GE Healthcare (China) Co., Ltd.
GE Proteus XR/A radiographic system
Open, Classified
KPRK993090
Sep 18, 2024PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
System Name: 708038 MultiDiagnost Eleva with Flat Detector 708037 MultiDiagnost Eleva with Flat Detector 708036 MultiDiagnost Eleva 708034 MultiDiagnost Eleva with Flat Detector 708032 MultiDiagnost E
Open, Classified
KPRK050151
Aug 26, 2024GE Healthcare (China) Co., Ltd.
GE Healthcare Proteus XR/a, stationary X-Ray System, Model/Catalog Numbers: 1) 2259973; 2) 2259988; 3) 2266999; 4) 2373519; 5) 2379827; 6) 5729352; 7) 2259973-1; 8) 2259973-2; 9) 2259973-3;
Open, Classified
KPRK993090
May 24, 2024FUJIFILM Healthcare Americas Corporation
FDR Visionary Suite - Intended to generate digital or conventional radiographic images of the skull, spinal column, chest, abdomen, extremities, and other body parts of human anatomies in all routine
Open, Classified
KPRK152294
Jan 23, 2024SEDECAL SA
Sedecal X Optima URS digital mobile diagnostic x-ray system. A a stationary x-ray unit with a universal swivel arm. It allows one to take exposures of patients in standing, sitting, or laying posi
Open, Classified
KPRK012546
Dec 14, 2023GE Hangwei Medical Systems, Co. LTD
The System is designed as a modular system with components that include an Overhead Tube Suspension with tube/collimator, wallstand, Table, X-ray generator, and cleared wireless digital detectors. The
Open, Classified
KPRK191699
Dec 14, 2023GE Hangwei Medical Systems, Co. LTD
The System is designed as a modular system with components that include an Overhead Tube Suspension with tube/collimator, wallstand, Table, X-ray generator, and cleared wireless digital detectors. The
Open, Classified
KPRK191699
Nov 8, 2023Philips North America Llc
DigitalDiagnost 4 Chest/Emergency, used to acquire, process, store, display and export digital radiographic images.
Open, Classified
KPRK210692
Sep 7, 2023Philips Medical Systems Nederland B.V.
MultiDiagnost-Eleva
Open, Classified
KPRK023441
K050151
Apr 12, 2023Philips North America Llc
DigitalDiagnost C50 1.1-intended for use in generating radiographic images of human anatomy Model Number : 712204
Open, Classified
KPRK163410
K201725
Apr 12, 2023Philips North America Llc
Philips DigitalDiagnost C50 -intended for use in generating radiographic images of human anatomy Model Number : 712201
Open, Classified
KPRK163410
K201725
Mar 2, 2023Carestream Health, Inc.
DRX-Compass/DR-FIT X-ray Systems with Firmware version 2.3.2.0/2.3.2.4. For use in obtaining diagnostic quality radiographic images to aid the physician with diagnosis. CATALOG #(s): 8624181 X-RAY S
Open, Classified
KPRK201373
Sep 1, 2022Philips North America Llc
DigitalDiagnost C50 1.1
Open, Classified
KPRK163410
K201725
Jul 12, 2022Philips Medical Systems DMC GmbH
DigitalDiagnost 4 High Performance. radiography and fluoroscopy system
Open, Classified
KPRK210692
Jul 12, 2022Philips Medical Systems DMC GmbH
DigitalDiagnost C90 Flex/Value/Chest/ER. radiography and fluoroscopy system
Open, Classified
KPRK202564
Jul 12, 2022Philips Medical Systems DMC GmbH
DigitalDiagnost C90 High Performance. radiography and fluoroscopy system
Open, Classified
KPRK202564
Jul 12, 2022Philips Medical Systems DMC GmbH
DigitalDiagnost 4 Flex / Value. radiography and fluoroscopy system
Open, Classified
KPRK210692
Jul 5, 2022Arcoma AB
Omnera 400A Digital Radiographic System
Open, Classified
KPRK140683
Jul 5, 2022Arcoma AB
Omnera 400T Digital Radiographic System
Open, Classified
KPRK140683
Mar 7, 2022Siemens Medical Solutions USA, Inc
YSIO X.Pree
Open, Classified
KPRK201670
Jan 31, 2022Siemens Medical Solutions USA, Inc
Ysiosystem with VC10 software version, Model Number 10281013. Radiographic system
Open, Classified
KPRK081722
Mar 10, 2021Siemens Medical Solutions USA, Inc
Ysio X.pree, Model Number: 11107464 - Product Usage: A Digital X-Ray System generate Xray images from the whole body including the skull, chest, abdomen, and extremities.
Terminated
KPRK201670
Jan 25, 2021Shanghai United Imaging Healthcare Co., Ltd.
Digitial Medica X-ray Imagining System, Model: uDR 596i, RX, CE0123, UDI:(01) 06971576833023 - Product Usage: intended to used by a qualified/trained doctor or technician on both adult and pediatric s
Terminated
KPRK181413
Dec 22, 2020EOS Imaging
The EOSedge system may acquire two simultaneous orthogonal planar images for a standing or seated patient at low dose. The scan length is defined by the user and may cover the whole body or a specific
Terminated
KPRK202394
Apr 7, 2020Philips North America, LLC
Philips TraumaDiagnost- a Stationary X-Ray System (Bucky System) Model: 720013 - Product Usage: general radiography.
Terminated
KPRK945278
Apr 6, 2020Siemens Medical Solutions USA, Inc
System AXIOM Aristos FX - Product Usage: A dedicated x-ray system with a flat panel detector which allows the acquisition of x-ray exposures without the use of conventional film/screen systems. The MP
Terminated
KPRK013826
Mar 3, 2020Siemens Medical Solutions USA, Inc
Ysio, model no. 10281013 Product Usage: The product is a stationary X-Ray system.
Terminated
KPRK081722
Feb 27, 2020Shanghai United Imaging Healthcare Co., Ltd.
uDR 596i Digital Medical X-Ray Imaging System - Product Usage: intended to use by a qualified/ trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exp
Terminated
KPRK181413
Jan 8, 2020Siemens Medical Solutions USA, Inc
SIEMENS Healthineers Ysio Max - Interventional Fluoroscopic X-Ray System, Model: 10762470 - Product Usage: is a device intended to visualize anatomical structures by converting an X-ray pattern into
Terminated
KPRK133259
Jan 8, 2020Siemens Medical Solutions USA, Inc
Ysio Max, model no. 10762470 - Product Usage: The Ysio Max is a radiographic system used in hospitals, clinics, and medical practices. Ysio Max enables radiographic and tomographic exposures f the who
Terminated
KPRK133259
Jan 6, 2020Carestream Health, Inc.
Kodak DirectView DR3000/3500 - Product Usage: permanently installed as a diagnostic system intended to generate and control x-rays for examination of various anatomical regions. The DR Operator Consol
Terminated
KPRK060550
Oct 15, 2019Cuattro LLC
CuattroDR System Software, REF: SWR-00069-MD, UDI: B269SWR00069MD0
Terminated
KPRK161937
Sep 20, 2019GE Healthcare, LLC
Proteus XR/a (SlOK : K993090)
Open, Classified
KPRK993090
Jul 30, 2019Shanghai United Imaging Healthcare Co., Ltd.
Digital Medical X-ray Imaging System, Model: uDR 596i, uDR 592h
Terminated
KPRK181413
Jun 10, 2019GE Healthcare, LLC
Silhouette VR This fully integrated system offers intuitive controls with advanced applications for maximum performance all in a space-saving design.
Terminated
KPRK982955
Jun 10, 2019GE Healthcare, LLC
Proteus XR/a The Proteus XR/a radiographic system offers the flexibility to choose a configuration based upon your specific requirements. The system provides exceptional image quality, high frequenc
Terminated
KPRK993090
Feb 28, 2019Philips North America, LLC
MultiDiagnost Eleva w/ Flat Detector, Product codes 708034, 708037, 708038 Product Usage: As a multifunctional I universal imaging application system, General RIF, Fluoroscopy, Radiography and Angiog
Terminated
KPRK050151
Dec 21, 2018Philips Healthcare
DigitalDiagnost C50, Stationary X-ray System
Terminated
KPRK163410
Dec 4, 2018Agfa-Gevaert, N.V.
DX-D 600 DIRECT RADIOGRAPHY SYSTEM Product Usage: The DX-D 600 system is a ceiling mounted General Radiography X-Ray imaging system used in hospitals, clinics and medical practices by physicists, rad
Terminated
KPRK112670
Sep 25, 2018Agfa N.V.
DX-D 600 Product Usage: The DX-D 600 system is a ceiling mounted General Radiography X-Ray imaging system used in hospitals, clinics and medical practices by physicists, radiographers and radiologist
Terminated
KPRK112670

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