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Emdyca

Bioimaging and radiotherapy instrumentsDigital bioimaging management instruments

Picture archiving and communication systems

EMDN code Z110603

99 manufacturers, 215 models including 195 on the market, 29 countries

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Manufacturers registered in Europe (EUDAMED) 99
  • 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.
ManufacturerCountryRegistered modelsClassContact
Change Healthcare Canada FDA EU representative : Emergo Europe B.V. (Netherlands) Canada
17 others
 IIa 93/42 EUDAMED record Report an error
GE Healthcare FDA EU representative : GE Medical Systems SCS (France) Germany, United States
9 others
 I, IIa MDR, 93/42 eudamed@gehealthcare.com EUDAMED record Report an error
Infinitt FDA EU representative : Obelis s.a. (Belgium) South Korea
3 others
 IIa 93/42 Website EUDAMED record Report an error
Philips FDA EU representative : Philips Medical Systems Nederland B.V. (Netherlands) Netherlands, United States
2 others
 I, IIa MDR, 93/42 eudamed@philips.com EUDAMED record Report an error
Wuhan ENDOANGEL Medical Technology EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China I MDR EUDAMED record Report an error
Disior FDA Finland I, IIa, IIb MDR, 93/42 Website EUDAMED record Report an error
Exini FDA Sweden IIa MDR Website info@exini.com EUDAMED record Report an error
MIM Software FDA EU representative : Emergo Europe B.V. (Netherlands) United States IIa 93/42 Website support@mimsoftware.com EUDAMED record Report an error
Sicat FDA Germany IIa MDR Website info@sicat.com EUDAMED record Report an error
DH Healthcare Germany IIa MDR Website EUDAMED record Report an error
Endovista EU representative : Everbiz GmbH (Germany) China I MDR EUDAMED record Report an error
Intelerad FDA EU representative : Emergo Europe B.V. (Netherlands) Canada, United States IIa MDR Website regulatory@intelerad.com EUDAMED record Report an error
Medical FDA EU representative : MDSS GmbH (Germany) Denmark, United States IIa MDR regulatory@mi.medical.canon EUDAMED record Report an error
MedicalCommunications FDA Germany IIa, IIb MDR, 93/42 EUDAMED record Report an error
Mirada Medical FDA EU representative : Emergo Europe B.V. (Netherlands) United Kingdom (ex Northern Ireland) IIa MDR Website info@mirada-medical.com EUDAMED record Report an error
Sectra FDA Sweden IIa MDR Website regulatoryaffairs@sectra.com EUDAMED record Report an error
Siemens Medical Solutions USA FDA EU representative : Siemens Healthcare GmbH (Germany) and 1 other United States IIa MDR Website contact@siemens-healthineers.com EUDAMED record Report an error
Visage Imaging FDA Germany IIa, IIb MDR Website support@visageimaging.com EUDAMED record Report an error
IMAGE Information Systems Europe FDA Germany
6 others
 I, IIa, IIb MDR, 93/42 Website info@iq-image.com EUDAMED record Report an error
Agfa HealthCare FDA Belgium IIa MDR Website EUDAMED record Report an error
Cercare Medical A S FDA Denmark IIa MDR Website info@cercare-medical.com EUDAMED record Report an error
E-COM Technology FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China IIa 93/42 EUDAMED record Report an error
Ebmtech FDA EU representative : International Associates Auditing & Certification Limited (Ireland) Taiwan IIa, IIb 93/42 Website ra.dept@ebmtech.com EUDAMED record Report an error
Ekstrem Bi̇r Bi̇lgi̇sayar Danişmanlik İç Ve Diş Ti̇caret Şi̇rketi̇ Türkiye IIb 93/42 Website EUDAMED record Report an error
Enovacom France I MDR, 93/42 Website EUDAMED record Report an error
Fujifilm FDA EU representative : FUJIFILM Healthcare Europe GmbH (Germany) United States IIa MDR EUDAMED record Report an error
Iasistech FDA Greece I MDR Website info@iasistech.gr EUDAMED record Report an error
ITH icoserve technology for healthcare Austria IIa 93/42 Website office@ith-icoserve.com EUDAMED record Report an error
medigration Germany I, IIb 93/42 Website info@medigration.de EUDAMED record Report an error
Novarad FDA EU representative : Emergo Europe B.V. (Netherlands) United States IIa MDR Website regulatory@novarad.net EUDAMED record Report an error
Oehm und Rehbein FDA Germany IIa MDR Website qualitymanagement@oehm-rehbein.de EUDAMED record Report an error
Synedra Austria IIb MDR Website office@synedra.com EUDAMED record Report an error
Tianjin Yujin Artificial Intelligence Medical Technology EU representative : MedPath GmbH (Germany) China I MDR EUDAMED record Report an error
Tired of Cancer Netherlands I MDR Website info@tiredofcancerapp.com EUDAMED record Report an error
Varian Medical Systems FDA EU representative : Siemens Healthineers Nederland B.V. (Netherlands) United States IIa, IIb MDR, 93/42 EUDAMED record Report an error
Synopsys FDA EU representative : Synopsys International Ltd. (Ireland) United Kingdom (ex Northern Ireland)
3 others
 IIa MDR, 93/42 Website EUDAMED record Report an error
Henry Schein One FDA EU representative : Advena Limited (Malta) United States I 93/42 EUDAMED record Report an error
"Софтуерна компания" ЕООД Bulgaria IIb 93/42 Website EUDAMED record Report an error
Acist FDA EU representative : ACIST Europe BV (Netherlands) United States I MDR Website EUDAMED record Report an error
Animati EU representative : EUROPE IONIC HEALTH DIGITAL TECHNOLOGIES LDA (Portugal) Brazil I MDR Website EUDAMED record Report an error
Aycan FDA Germany IIa MDR Website info@aycan.de EUDAMED record Report an error
Biotronics 3D FDA EU representative : Skyer Medical Imaging S.R.L. (Romania) United Kingdom (ex Northern Ireland) IIa MDR Website support@biotronics3d.com EUDAMED record Report an error
BMD Software Portugal IIa MDR Website info@bmd-software.com EUDAMED record Report an error
Coreline Soft FDA EU representative : JaviTech e.K. (Germany) South Korea IIa 93/42 rat@corelinesoft.com EUDAMED record Report an error
D.A.T.A Austria IIb MDR Website office@data.at EUDAMED record Report an error
DeepHealth FDA EU representative : MedEnvoy Global BV (Netherlands) United States I MDR Website regulatory@deephealth.com EUDAMED record Report an error
Dentaleye Sweden IIa MDR Website info@dentaleye.com EUDAMED record Report an error
digipaX Germany IIb MDR Website info@digipax.de EUDAMED record Report an error
Digithurst Germany IIb 93/42 EUDAMED record Report an error
Drgem FDA EU representative : Obelis s.a. (Belgium) South Korea I MDR Website EUDAMED record Report an error
eRAD FDA EU representative : Képdoktor Számítástechnikai, Kereskedelmi és Fejlesztő Kft. (Hungary) United States IIa MDR Website eudamedinquiries@erad.com EUDAMED record Report an error
Focal Healthcare FDA EU representative : Obelis s.a. (Belgium) Canada IIa MDR regulatory@focalhealthcare.com EUDAMED record Report an error
Fotofinder FDA Germany I MDR Website info@fotofinder.de EUDAMED record Report an error
Fysicon FDA Netherlands I MDR Website info@fysicon.com EUDAMED record Report an error
Hanalytics Pte EU representative : Medical Technology Promedt Consulting GmbH (Germany) Singapore IIa 93/42 Website qa.ra@biomind.ai EUDAMED record Report an error
Hangzhou AI-MU Meditec FDA EU representative : Everbiz GmbH (Austria) China I MDR EUDAMED record Report an error
Healthcare Experience Ανωνυμη Εταιρεια Ολοκληρωμενων Λυσεων Ιατρικης Πληροφορικης Ιατρικου Εξοπλιμου-Λογισμικου Και Υπηρεσιων Greece I MDR Website info@he-experience.com EUDAMED record Report an error
Heidelberg Engineering FDA Germany IIb MDR EUDAMED record Report an error
Huiying Medical Technology (Beijing) EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China I MDR EUDAMED record Report an error
Icz Hea Czechia IIb 93/42 Website marketing@i.cz EUDAMED record Report an error
Info World Romania I MDR Website EUDAMED record Report an error
Infomedica Croatia I MDR Website info@infomedica.hr EUDAMED record Report an error
Inspektor Netherlands I MDR Website info@inspektor.nl EUDAMED record Report an error
Konica Minolta FDA EU representative : Konica Minolta Business Solutions Europe GmbH (Netherlands) Japan IIa MDR EUDAMED record Report an error
Lunit FDA EU representative : MedEnvoy Global BV (Netherlands) New Zealand I 93/42 Website EUDAMED record Report an error
M.I. Medical Italy IIb 93/42 info@mimedical.it EUDAMED record Report an error
Medimatic FDA Italy IIa MDR Website info@medimatic.com EUDAMED record Report an error
Medoro Czechia IIb MDR Website info@medoro.org EUDAMED record Report an error
Medsynaptic EU representative : International Associates Auditing & Certification Limited (Ireland) India I MDR Website sales@medsynaptic.com EUDAMED record Report an error
Merge Healthcare FDA EU representative : Emergo Europe B.V. (Netherlands) United States IIa, IIb MDR, 93/42 EUDAMED record Report an error
Meso Germany I MDR Website info@meso.biz EUDAMED record Report an error
Mindray FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China I MDR Website EUDAMED record Report an error
MPTronic France I MDR Website info@mptronic.com EUDAMED record Report an error
Navbit FDA EU representative : Emergo Europe B.V. (Netherlands) Australia IIa MDR Website EUDAMED record Report an error
Neagen Finland IIa 93/42 Website info@neagen.com EUDAMED record Report an error
Neusoftmedical FDA EU representative : Emergo Europe B.V. (Netherlands) China IIa 93/42 EUDAMED record Report an error
Nexus / Chili FDA Germany IIb MDR compliance@nexus-chili.com EUDAMED record Report an error
NEXUS Enterprise Imaging Germany IIb MDR Website info@enterprise-imaging.de EUDAMED record Report an error
Orcz Czechia IIb MDR, 93/42 Website EUDAMED record Report an error
PixelData Romania I 93/42 Website infopxd@pixeldata.ro EUDAMED record Report an error
Radpoint Poland I MDR Website office@radpoint.pl EUDAMED record Report an error
Shanghai United Imaging Healthcare FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China IIa MDR services@united-imaging.com EUDAMED record Report an error
Simplex Bilgi Teknolojileri A.Ş Türkiye IIb 93/42 info@simplexbt.com EUDAMED record Report an error
Softjump EU representative : MedEnvoy Global BV (Netherlands) United Kingdom (ex Northern Ireland) I MDR Website EUDAMED record Report an error
Softmed Poland IIa MDR Website EUDAMED record Report an error
Stryker FDA EU representative : Stryker European Operations Limited (Ireland) United States I MDR Website EUDAMED record Report an error
Synaptive Medical FDA EU representative : MDSS GmbH (Germany) Canada IIa MDR Website service@synaptivemedical.com EUDAMED record Report an error
Synektik Poland IIb 93/42 Website EUDAMED record Report an error
Telemis Belgium, Germany IIa, IIb 93/42 Website info@telemis.de EUDAMED record Report an error
Unident Sweden IIa MDR Website EUDAMED record Report an error
Uraltelekom Türkiye I MDR Website info@uraltelekom.com EUDAMED record Report an error
Vepro FDA Germany IIa MDR Website EUDAMED record Report an error
Vieworks FDA EU representative : Vieworks EU GmbH (Germany) South Korea IIa 93/42 Website regulatory@vieworks.com EUDAMED record Report an error
Visionary Intelligence EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China I MDR Website contactus@vistel.cn EUDAMED record Report an error
Visus FDA Germany IIa MDR Website info@visus.com EUDAMED record Report an error
Zed Technologies FDA EU representative : Donawa Lifescience Consulting Srl (Italy) Australia IIa MDR Website support@zedtechnologies.com.au EUDAMED record Report an error
Zeiss FDA Germany IIa MDR Website EUDAMED record Report an error
Zhenhealth EU representative : MedPath GmbH (Germany) China I MDR EUDAMED record Report an error
Zio FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany) Japan IIa 93/42 EUDAMED record Report an error

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) 54

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.

ManufacturerCountryBrandsFDA clearance
Topcon Healthcare Solutions EMEA Oy Present in Europe in other categories Finland Harmony IMAGEnet 6 Glaucoma Module Harmony Referral System K253893 (2026)
TOPCON HEALTHCARE INC Present in Europe in other categories United States Harmony Synergy ODM registered
Nidek, Inc. Present in Europe in other categories United States AL-Scan Viewer for NAVIS-EX CEM Viewer for NAVIS-EX Image filing software NAVIS-EX Image filing software Scanning Laser Ophthalmoscope Data Acquisition Service for NAVIS-EX K181345 (2018)
Canon, Inc. Present in Europe in other categories United States CANON INC. K201273 (2020)
Eigen Health Services LLC – Artemis-TPOS Artemis registered
Haag-Streit AG Present in Europe in other categories Switzerland EyeSuite Software K142423 (2014)
Topcon Corporation Present in Europe in other categories Japan IMAGEnet 5 OPHTHALMIC DATA SYSTEM IMAGEnet 6 OPHTHALMIC DATA SYSTEM K232828 (2024)
COSTRUZIONI STRUMENTI OFTALMICI C.S.O. SRL – S4 OPTIK registered
Centervue S.P.A. Present in Europe in other categories Italy iCare ALTIUS CW K234076 (2024)
Diagnos Inc United States CARA K110869 (2011)
ESSILOR INTERNATIONAL Present in Europe in other categories United States ANAEYES OCT for system linkage registered
Huvitz Co., Ltd. Present in Europe in other categories South Korea Huvitz Integrated Image Server HIIS-1 K191615 (2019)
INTELLIGENT RETINAL IMAGING SYSTEMS, LLC United States IRIS K141922 (2015)
Indica Labs, Inc. Present in Europe in other categories United States HALO AP Dx K252762 (2025)
Integrated Ophthalmic Systems, Inc. United States Continuum PACS K200385 (2020)
JelloX Biotech Inc. Taiwan JelloX K240303 (2024)
OMNYX, LLC – Dynamyx Digital Pathology Software registered
OPTOS PUBLIC LIMITED COMPANY – OPTOS ADVANCE registered
Ophthalmic Labs, Inc. United States OVision Imaging System K200275 (2020)
Optina Diagnostiques, Inc – Mydriatic Hyperspectral Retinal Camera registered
Paige.Ai, Inc. Present in Europe in other categories United States FullFocusTM Whole Slide Image Viewer K241273 (2025)
PathAI, Inc. Present in Europe in other categories United States AISight Dx K243391 (2025)
PathPresenter, Corporation Present in Europe in other categories United States PathPresenter Clinical Viewer K250968 (2025)
REMIDIO INNOVATIVE SOLUTIONS PRIVATE LIMITED India Remidio registered
SHANDON DIAGNOSTICS LIMITED Present in Europe in other categories United Kingdom Epredia registered
Siemens Healthcare GmbH Present in Europe in other categories Germany myAblation Guide K253264 (2026)
Sonomed, Inc. Present in Europe in other categories United States AXIS Image Management System K171098 (2017)
TRIBUN HEALTH Present in Europe in other categories France CaloPix K250414 (2025)
Welch Allyn, Inc. Present in Europe in other categories United States Welch Allyn, Inc. K181016 (2018)
Aetherai Co., Ltd. Present in Europe in other categories Taiwan – K233126 (2024)
Altris, Inc. Present in Europe in other categories United States – K232088 (2023)
Avnet, Inc. United States – registered
Baxter Healthcare Corp Present in Europe in other categories United States – registered
Canon Inc. -Medical Equipment Group Japan – K173689 (2018)
Eigen United States – K222222 (2023)
Elekta , Ltd. Present in Europe in other categories United Kingdom – registered
Epredia Holdings Ltd. United States – registered
HistoSonics, Inc. United States – K252947 (2026)
Inspirata, Inc. United States – K210811 (2022)
KONAN MEDICAL USA, INC. Present in Europe in other categories Japan – K203244 (2021)
Kowa Co. , Ltd. Present in Europe in other categories Japan – registered
Kowa Co. Ltd. Chofu Japan – K190056 (2019)
Lumea, Inc. United States – K242244 (2025)
Merit Cro, Inc. United States – K220929 (2022)
Neurovision Imaging, LLC United States – K181501 (2018)
Optina Diagnostics, Inc. Canada – registered
Optos Plc. Present in Europe in other categories United States – K162039 (2017)
Proscia, Inc. Present in Europe in other categories United States – K261380 (2026)
R.A.W. S.R.L Italy – K222938 (2023)
Retinai Medical AG Switzerland – K211715 (2022)
Techsomed Israel – K240773 (2024)
Techsomed Medical Technologies Israel – K251931 (2025)
Topcon Medical Systems, Inc. Present in Europe in other categories United States – K182376 (2018)
Visionquest Biomedical, Inc. United States – K200422 (2020)

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