Bioimaging and radiotherapy instrumentsDiagnostic and interventional radiology instruments
Direct digital radiology (dr) systems
EMDN code Z110311
Manufacturers registered in Europe (EUDAMED) 53
- On the market
- No longer marketed
- 93/42 Former directive, not yet certified under the MDR
- Click a manufacturer to see its full range, a model to open its EUDAMED record.
A model registered in EUDAMED is not necessarily sold in your country. Check availability and CE marking with the manufacturer.
Other manufacturers known in the United States (FDA) 93
Manufacturers selling this type of device in the United States according to the FDA, not yet in EUDAMED for this category. Some do sell in Europe: registration of devices already on the market is mandatory until 28 November 2026, and some are registered under their parent company’s name. The category is inferred automatically from the US classification and may include related products.
| Manufacturer | Country | Brands | FDA clearance |
|---|---|---|---|
| SIRONA DENTAL, INC. | – | SCHICK ELITE Schick AE SCHICK33 XIOS AE FONA STELLARIS | registered |
| Dentsply Intl. Present in Europe in other categories | United States | Schick Xios XG Supreme | registered |
| Sedecal., Sa. Present in Europe in other categories | United States | SEDECAL Philips | K133782 (2014) |
| Imaging Dynamics Company , Ltd. | Canada | Aquarius 8600 Xplorer 2200 Digital Radiographic System X3C 1600 Plus Digital Radiographic System X3C 1600 Digital Radiographic System X3C 1100 Digital Radiographic System Xplorer 1500 Digital Radiographic System | K173273 (2017) |
| KONICA MINOLTA MEDICAL IMAGING U.S.A., INC. | – | CR Reader RF 11X14 Sensor Panel 1717 Flat Panel Detector RF 14X17 Sensor Panel Konica Minolta Ultra Software 17X17 GOS Fixed Flat Panel Detector | registered |
| Minxray, Inc. | United States | MinXray | registered |
| Shimadzu Corp. Present in Europe in other categories | United States | RADspeed Pro FDR Visionary Suite RADspeed fit | K050925 (2005) |
| iRay Imaging Technology Taicang Limited | China | iRay iRay(k) iRay(k Taicang) Mano4336W(k Taicang) Mano4343W(k Taicang) Mano4343W | registered |
| AADCO MEDICAL, INC. | United States | AADCO | registered |
| Meridian Medical Systems, LLC Present in Europe in other categories | United States | Monarch | K143232 (2015) |
| Lg Electronics.Inc Present in Europe in other categories | South Korea | LG | K223546 (2023) |
| RADLINK, INC. | United States | Radlink Cassette Radlink DR Pro 2200 Radlink CR Pro 2200 Radlink DR Tablet Retrofit Radlink GPS Tablet 2200 Radlink GPS Tablet Stand | K142718 (2014) |
| Pixxgen Corporation Present in Europe in other categories | South Korea | PIXX1212 PIXX1717 PIXX1417 Prudent1417 Prudent1212 Prudent1717 | K211108 (2021) |
| Digiray Corp. Present in Europe in other categories | South Korea | FireCR Spark Cassette 18cmx24cm(IP 18cmx24cm)Kit Universal Cassette 24cmx30cm(IP 24cmx30cm)Kit FireCR Flash Cassette 24cmx30cm(IP 24cmx30cm)Kit FireCR | registered |
| Varex Imaging Corporation Present in Europe in other categories | United States | Varex Digital Imaging System, Nexus, RF/DR, Digital Receptor Varex Digital Imaging System, Nexus, DR, Digital Receptor Varex Digital Imaging Software, Nexus DRF, v3.5 Varex Digital Imaging Software, Nexus, DRF, v3.7 XRpad2 Varex Digital Imaging Software, Nexus DR, v4.18 | K193238 (2019) |
| Alliage S/A Indústrias Médico Odontológica Present in Europe in other categories | Brazil | Intraoral Dental Digital Imaging Sensor EVOLVE SENSOR | registered |
| PerkinElmer Technologies GmbH & Co. KG | – | XRpad Digital X-Ray Detector System | registered |
| Tuxedo Imaging LLC | United States | Tuxedo | registered |
| Bontech, Inc. Present in Europe in other categories | South Korea | BSD3543 Digital Flat Panel X-ray Detector BSD3543W Digital Flat Panel X-ray Detector BSD4343R Digital Flat Panel X-ray Detector BONX805, DIONE-X80 Portable X-ray Imaging Device | K200787 (2020) |
| GE Medical Systems Present in Europe in other categories | United States | Flashpad HD Optima AMX Definium | K102615 (2010) |
| Radmedix, LLC | United States | AcuityDRe Radmedix AcuityDRe 1417w Radmedix AcuityDR 1417 G4 Radmedix AcuityDRe 1717t Radmedix AcuityDRe 1717w Radmedix AcuityDR 1013 G4 | K231709 (2023) |
| Ziehm-Orthoscan, Inc. Present in Europe in other categories | United States | OrthoScan Pulse Mini C-arm Orthoscan TAU MVP 1515 TAU Model 1000-0016 Mini C-Arm Orthoscan TAU MVP 2020 Orthoscan Versa Mini C-Arm TAU Model 1000-0015 Mini C-Arm | registered |
| LED Dental Inc | Canada | Tuxedo | K153710 (2016) |
| Nano-X Imaging , Ltd. | Israel | TAP2D Nanox.ARC X Nanox.ARC | K252649 (2026) |
| Air Techniques, Inc. Present in Europe in other categories | United States | ScanX 12 SE ScanX Quantum (with battery) ScanX Fit (without battery) ScanX Fit (with battery) ScanX Quantum (without battery) | K101289 (2010) |
| MICRO-X LIMITED Present in Europe in other categories | Australia | Micro-X | registered |
| The Perkin-Elmer Corp. | United States | XRpad Digital X-Ray Detector System | K161966 (2016) |
| BLUO ELECTRONICS SRL | – | PantOs 16 xp PantOs DG xp PantOs 16 xp Ceph | registered |
| IcRco, Inc. | United States | AirDR iDR | K113449 (2012) |
| VAREX IMAGING WEST, LLC | – | XRPad2 XRpad | registered |
| Palodex Group OY Present in Europe in other categories | Finland | DIGORA Optime Scan eXam | registered |
| ASTEL Inc. | South Korea | RFA-1717DIC RFA-1717DIG | K212051 (2021) |
| Arcoma AB | Sweden | OMNERA 400A OMNERA 400T | registered |
| Biokinemetrics, Inc. | United States | ChiroSight Flat Panel Wireless and Software ChiroSight Flat Panel and Software | K190311 (2019) |
| Dentium Co., Ltd Present in Europe in other categories | South Korea | Intra Oral Sensor | registered |
| NICAL SPA | Italy | Nical Flat Panel | K053029 (2006) |
| Omega Medical Imaging, LLC | United States | Omega Medical Imaging Omega Medical Imaging, LLC | registered |
| Osko, Inc. | United States | Edge Air Edge | K201503 (2020) |
| Ray Co., Ltd. Present in Europe in other categories | South Korea | RIOSensor | K143000 (2015) |
| Del Medical, Inc. | United States | Del Medical, Inc. | K140825 (2014) |
| First Source, Inc. | United States | iQ View | K203703 (2021) |
| Halifax Biomedical Incorporated | United States | Halifax Imaging Kit | registered |
| KA Imaging Inc Present in Europe in other categories | Canada | Reveal 35C | K201591 (2020) |
| Medicatech USA | United States | MasteRad | K230918 (2023) |
| Neurologica Corporation | United States | GMR40 Retrofit Kit | registered |
| Radiology Information Systems, Inc. | United States | Radiology Information Systems, Inc. | registered |
| UIH TECHNOLOGIES LLC | United States | uDR | registered |
| iRay Korea Limited | South Korea | Wireless Digital Flat Panel Detector | registered |
| ANDA Medical | Canada | – | registered |
| Agfa Healthcare N.V. Present in Europe in other categories | United States | – | K172784 (2017) |
| Aspen Imaging Healthcare, Inc. | United States | – | K241346 (2024) |
| Block Imaging SAS | United States | – | registered |
| COMPASS INNOVATIONS, INC | United States | – | registered |
| Can Technomed Trading LTD. | Canada | – | registered |
| Canon Inc. -Medical Equipment Group | Japan | – | K162909 (2017) |
| Careray Digital Medical System Co., Ltd. | China | – | K202995 (2021) |
| DENTSPLY SIRONA INC | United States | – | registered |
| DHL Supply Chain (Netherlands) B.V. | Netherlands | – | registered |
| Dentium Co., Ltd (Ict Branch) Present in Europe in other categories | South Korea | – | K201247 (2020) |
| EverX / Bindra | Australia | – | registered |
| Fair Medical Co.,Ltd | Japan | – | registered |
| GE HealthCare Technologies Inc. Present in Europe in other categories | United States | – | registered |
| IRAY Imaging LLC | United States | – | registered |
| Innolux Corporation | Taiwan | – | K162344 (2016) |
| Iray Imaging Technology (Haining) Limited | China | – | K252911 (2025) |
| Iray Technology (Shanghai) , Ltd. | China | – | K161730 (2016) |
| Iray Technology Taicang , Ltd. | China | – | K222886 (2022) |
| Kuehne GmbH | Germany | – | registered |
| LG Electronics Inc Monitor Division. | South Korea | – | registered |
| Livermoretech, Inc. | United States | – | K193644 (2020) |
| Medical Resale PTY Limited | Australia | – | registered |
| Medien International Co, Ltd. | United States | – | K172435 (2017) |
| Neurologica Corporation, A Subsidiary OF | United States | – | K171085 (2017) |
| Pausch Corp. | United States | – | K973864 (1998) |
| Pausch Medical GmbH | Germany | – | K221949 (2023) |
| Prognosys Medical Systems | India | – | registered |
| Pzmedical Technology Co., Ltd. Present in Europe in other categories | China | – | K212105 (2021) |
| Ray Imaging Technology (Haining) Limited | China | – | K230059 (2023) |
| Sanicure BV | Netherlands | – | registered |
| Scandinavian Medical Solutions A/S | Denmark | – | registered |
| Shanghai PZ Medical Technolgoy Co., Ltd. | China | – | K170480 (2017) |
| Siemens Healthineers AG Present in Europe in other categories | Germany | – | registered |
| Siemens Medical Solutions USA, Inc. Present in Europe in other categories | United States | – | K061054 (2006) |
| Source-Ray, Inc. | United States | – | registered |
| Summit Industries, Inc. Present in Europe in other categories | United States | – | registered |
| Televere Systems | United States | – | K172124 (2017) |
| The Kretchmer Corp. | United States | – | registered |
| VATECH Co., Ltd. Present in Europe in other categories | United States | – | K101590 (2010) |
| Varian Medical Systems, X-Ray Products-Infimed | United States | – | K161459 (2016) |
| Viztek, LLC | United States | – | K160810 (2016) |
| XLINE S.r.l. | Italy | – | registered |
| Zentech Manufacturing, Inc | United States | – | registered |
| Zot Engineering Limited | United Kingdom | – | registered |
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