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) |
|---|---|---|---|
| Feb 5, 2026 | FUJIFILM Healthcare Americas Corporation FDR Visionary Suite;
Model Number: CH-200;
Version: (1) 566-16130-23, (2) 566-16130-31, (3) Open, Classified |
KPR | K152294 |
| Nov 7, 2025 | Philips Medical Systems DMC GmbH Radiography 7300 C;
Model Number: 712037; Open, Classified |
KPR | K233662 |
| Nov 7, 2025 | Philips Medical Systems DMC GmbH DigitalDiagnost 4 (1) High Performance, (2) Flex/Value;
Model Number: (1) 712031, (2) 712032; Open, Classified |
KPR | K210692 |
| Oct 7, 2025 | FUJIFILM 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 |
KPR | K152294 |
| Apr 11, 2025 | Philips North America Llc Philips DXR System, DuraDiagnost Rel. 4. Stationary X-Ray System. Open, Classified |
KPR | K141381 K201640 |
| Apr 11, 2025 | Philips North America Llc Philips DXR System, DuraDiagnost 4.1. Stationary X-Ray System. Open, Classified |
KPR | K141381 K201640 |
| Feb 3, 2025 | GE Medical Systems, LLC Optima XR646 HD. X-Ray imaging system. Open, Classified |
KPR | K173612 |
| Feb 3, 2025 | GE Medical Systems, LLC Discovery XR656 HD. X-Ray imaging system. Open, Classified |
KPR | K172869 |
| Feb 3, 2025 | GE Medical Systems, LLC Discovery XR656HD. X-Ray imaging system. Open, Classified |
KPR | K191699 |
| Feb 3, 2025 | GE Medical Systems, LLC Definium 656HD & Discovery XR656HD (GTINs: 00840682138598, 00195278840226, 00840682136709). X-Ray imaging system. Open, Classified |
KPR | K231892 |
| Nov 25, 2024 | GE Healthcare (China) Co., Ltd. GE Proteus XR/A radiographic system Open, Classified |
KPR | K993090 |
| Sep 18, 2024 | PHILIPS 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 |
KPR | K050151 |
| Aug 26, 2024 | GE 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 |
KPR | K993090 |
| May 24, 2024 | FUJIFILM 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 |
KPR | K152294 |
| Jan 23, 2024 | SEDECAL 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 |
KPR | K012546 |
| Dec 14, 2023 | GE 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 |
KPR | K191699 |
| Dec 14, 2023 | GE 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 |
KPR | K191699 |
| Nov 8, 2023 | Philips North America Llc DigitalDiagnost 4 Chest/Emergency, used to acquire, process, store, display and export digital radiographic images. Open, Classified |
KPR | K210692 |
| Sep 7, 2023 | Philips Medical Systems Nederland B.V. MultiDiagnost-Eleva Open, Classified |
KPR | K023441 K050151 |
| Apr 12, 2023 | Philips North America Llc DigitalDiagnost C50 1.1-intended for use in generating radiographic images of human anatomy
Model Number : 712204 Open, Classified |
KPR | K163410 K201725 |
| Apr 12, 2023 | Philips North America Llc Philips DigitalDiagnost C50 -intended for use in generating radiographic images of human anatomy
Model Number : 712201 Open, Classified |
KPR | K163410 K201725 |
| Mar 2, 2023 | Carestream 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 |
KPR | K201373 |
| Sep 1, 2022 | Philips North America Llc DigitalDiagnost C50 1.1 Open, Classified |
KPR | K163410 K201725 |
| Jul 12, 2022 | Philips Medical Systems DMC GmbH DigitalDiagnost 4 High Performance. radiography and fluoroscopy system Open, Classified |
KPR | K210692 |
| Jul 12, 2022 | Philips Medical Systems DMC GmbH DigitalDiagnost C90 Flex/Value/Chest/ER. radiography and fluoroscopy system Open, Classified |
KPR | K202564 |
| Jul 12, 2022 | Philips Medical Systems DMC GmbH DigitalDiagnost C90 High Performance. radiography and fluoroscopy system Open, Classified |
KPR | K202564 |
| Jul 12, 2022 | Philips Medical Systems DMC GmbH DigitalDiagnost 4 Flex / Value. radiography and fluoroscopy system Open, Classified |
KPR | K210692 |
| Jul 5, 2022 | Arcoma AB Omnera 400A Digital Radiographic System Open, Classified |
KPR | K140683 |
| Jul 5, 2022 | Arcoma AB Omnera 400T Digital Radiographic System Open, Classified |
KPR | K140683 |
| Mar 7, 2022 | Siemens Medical Solutions USA, Inc YSIO X.Pree Open, Classified |
KPR | K201670 |
| Jan 31, 2022 | Siemens Medical Solutions USA, Inc Ysiosystem with VC10 software version, Model Number 10281013. Radiographic system Open, Classified |
KPR | K081722 |
| Mar 10, 2021 | Siemens 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 |
KPR | K201670 |
| Jan 25, 2021 | Shanghai 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 |
KPR | K181413 |
| Dec 22, 2020 | EOS 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 |
KPR | K202394 |
| Apr 7, 2020 | Philips North America, LLC Philips TraumaDiagnost- a Stationary X-Ray System (Bucky System) Model: 720013 - Product Usage: general radiography. Terminated |
KPR | K945278 |
| Apr 6, 2020 | Siemens 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 |
KPR | K013826 |
| Mar 3, 2020 | Siemens Medical Solutions USA, Inc Ysio, model no. 10281013
Product Usage: The product is a stationary X-Ray system. Terminated |
KPR | K081722 |
| Feb 27, 2020 | Shanghai 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 |
KPR | K181413 |
| Jan 8, 2020 | Siemens 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 |
KPR | K133259 |
| Jan 8, 2020 | Siemens 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 |
KPR | K133259 |
| Jan 6, 2020 | Carestream 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 |
KPR | K060550 |
| Oct 15, 2019 | Cuattro LLC CuattroDR System Software, REF: SWR-00069-MD, UDI: B269SWR00069MD0 Terminated |
KPR | K161937 |
| Sep 20, 2019 | GE Healthcare, LLC Proteus XR/a (SlOK : K993090) Open, Classified |
KPR | K993090 |
| Jul 30, 2019 | Shanghai United Imaging Healthcare Co., Ltd. Digital Medical X-ray Imaging System, Model: uDR 596i, uDR 592h Terminated |
KPR | K181413 |
| Jun 10, 2019 | GE Healthcare, LLC Silhouette VR
This fully integrated system offers intuitive controls with advanced applications for maximum performance all in a space-saving design. Terminated |
KPR | K982955 |
| Jun 10, 2019 | GE 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 |
KPR | K993090 |
| Feb 28, 2019 | Philips 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 |
KPR | K050151 |
| Dec 21, 2018 | Philips Healthcare DigitalDiagnost C50, Stationary X-ray System Terminated |
KPR | K163410 |
| Dec 4, 2018 | Agfa-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 |
KPR | K112670 |
| Sep 25, 2018 | Agfa 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 |
KPR | K112670 |
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