Bioimaging and radiotherapy instruments
Radiotherapy and radiosurgery instruments
EMDN code Z1101
Manufacturers registered in Europe (EUDAMED) 26
- 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.
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Other manufacturers known in the United States (FDA) 184
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 |
|---|---|---|---|
| Best Medical International, Inc. | United States | Best Medical International | K162499 (2018) |
| MICK RADIO NUCLEAR INSTRUMENT, INC | – | MRNI HDR SARCOMA NEEDLE 17G x 28cm MICK TP Needle,18G,25cm,Disp, (25pc) Mick 3mm gold fiduciary marker,17G,single (10pc) Mick 5mm gold fiduciary marker,17G,single (10pc) MICK TP Needle,17G,25cm,Disp, (25pc) MICK 3mm Gold Fiduciary Marker, 17G Single | registered |
| Liberty Medical , Inc. | United States | Flexi-Needle Buttons Medium Prostate Brachytherapy Kit Adapter Intrauterine Tandem Implant Needle | registered |
| Theragenics Corp. | United States | Theragenics SeedLock I-Seed Agx100 TheraSeed TheraMark™ TheraStrand® with I-Seed | K103319 (2011) |
| PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH Present in Europe in other categories | – | DIAMENTOR OCTAVIUS RW3 slab phantom RUBY MP1 Manual Water Phantom | registered |
| Lap GmbH Laser Applikationen Present in Europe in other categories | Germany | EASY CUBE EASY SLAB | registered |
| MEDI-PHYSICS, INC. | United States | OncoSeedTM RAPID STRANDTM I-125 SeedsTM in Carrier RAPID StrandTM Rx RAPID StrandTM Rx MICK Thin SeedTM Iodine-126 | K122764 (2012) |
| RIVERPOINT MEDICAL, LLC | United States | GOLD MARKER NEEDLE RIVERPOINT BRACHYTHERAPY GOLD FIDUCIAL MARKER FIDUCIAL NEEDLES BRACHYTHERAPY NEEDLE | K103449 (2011) |
| Modus Medical Devices Inc | Canada | QUASAR Vista ClearView QUASAR Static Phantom IBA QUASAR™ Programmable Respiratory Motion Phantom 2 | registered |
| CIVCO Medical Instruments Co., Inc. | United States | Cradle Classic Stepper Multi-Purpose Workstation™ Stepper EX3 Stepper Template Grid Micro-Touch® Stabilizer LP | registered |
| IBA Dosimetry GmbH Present in Europe in other categories | Germany | miniPhantom myQA® SRS Phantom myQA® SRS Phantom Cyberknife miniPhantom R KermaX-plus DOSE-X | registered |
| Xcision Medical Systems, LLC | United States | GammaPod™ Breast Immobilization and Localization System GammaPod™ GammaPod™ Imager Loader and Couch GammaPod™ Treatment Control System GammaPod™ Treatment Planning System | K180571 (2018) |
| Bard Brachytherapy, Inc. | – | BrachyStar™ QuickLink™ BrachyStar™, FastFill™ TheraSeed® BrachySource™ QuickLink™, SourceLink™ | registered |
| Izi Medical Products, LLC Present in Europe in other categories | United States | VISICOIL Gold Fiducial VISICOIL MR Twin Line 2PK 0.8X3.0MM GOLD FIDUCIAL LOOSE | registered |
| STELLAR MEDICAL, LLC | United States | Stellar Medical | registered |
| Isoaid, LLC | United States | Advantage I-125® Advantage Pd-103® Advantage I-125 IsoSphere Advantage-Strand® with Advantage I-125® Advantage-Load® with Advantage Pd-103® | K242818 (2025) |
| Elekta Instrument AB | Sweden | Leksell Gamma Knife Perfexion/Icon Leksell Gamma Knife Icon Leksell GammaPlan Leksell Gamma Knife C 4 4C Leksell Gamma Knife Perfexion Leksell Stereotactic System | K173789 (2018) |
| ADVANCED RADIATION THERAPY, LLC | United States | AccuBoost AccuBoost® | K062135 (2006) |
| ACTION PRODUCTS, INC. Present in Europe in other categories | United States | Action® | K811528 (1981) |
| Best Nomos | United States | Reusable Frame, Bard SurePoint Stepper Reusable Frame, CMS AccuSeed Disposable Template, 17 Gauge, Siemens, Single Best Precision Stabilizer Disposable Template, 18 Gauge, Siemens, 5 Pack Reusable Template, Best Precision Stepper, 17 Gauge, Non-Siemens Ultrasound | K211034 (2021) |
| Icad, Inc. | United States | Balloon Applicator HDR X-ray Source 2.2 Balloon Applicator Kit (10) Applicator End Cap, 35 mm Vaginal Applicator Set with Base and Clamp Surface Applicator Cone, 10 mm | K153570 (2016) |
| RaySearch Laboratories AB (PUBL) | Sweden | RayStation RayCare | K252109 (2025) |
| Alpha-Omega Services, Inc. | United States | AOS Interstitial Templates, Needles, and Accesories AOS Universal Connecting Guide Tubes AOS Interstitial Templates, Needles, and Accessories AOS Extension Adaptor AOS Retaining Button (Syed Type), Radiopaque AOS Retaining Button (Syed Type), White Nylon | K233628 (2024) |
| Kobold, LLC | United States | Kobold® Prostate HDR Template - 17 ga/4 Fr Kobold® Fletcher-model Tandem and Cylinder Ovoid Applicator Set (E) Kobold® Prostate HDR Template - 16 ga/5 Fr Kobold® Prostate HDR Stepper Template - 17 ga/4 Fr Kobold® Tandem and 30 Deg Ring Applicator Set (E) Kobold® Vaginal Cylinder Applicator Set (E) | K170203 (2017) |
| Providus Holdings, Inc. | – | LiquiPhil™ Rando® | registered |
| Nucletron Corp. Present in Europe in other categories | United States | Esteya | K213942 (2022) |
| Sun Nuclear Corp. Present in Europe in other categories | United States | ISORAD Detector, 1-4MV (+) 3m ISORAD Detector, 6-12MV (-) 1.5m ISORAD Detector, 6-12MV (-) 3m ISORAD Detector, 6-12MV (+) 3m ISORAD Detector, 1-4MV (-) 3m ISORAD Detector, 15-25MV (-) 1.5m | registered |
| Merit Medical Systems, Inc. Present in Europe in other categories | United States | SAVI® | registered |
| Gt Medical Technologies | United States | CS-1 PL-4 PL-3 PL-5 PL-2 PL-4NS | K221539 (2022) |
| Mim Software, Inc. Present in Europe in other categories | United States | ContourProtégéAI ContourProtégéAI - CT Abdomen ContourProtégéAI - CT Liver ContourProtégéAI - CT Lung and Liver ContourProtégéAI - CT Prostate ContourProtégéAI - CT Head and Neck | K253270 (2026) |
| Prowess, Inc. | United States | Panther TPS Panther OIS | K231825 (2023) |
| Siemens Healthcare GmbH Present in Europe in other categories | Germany | syngo.via RT Image Suite syngo VSim syngo.via RT Image Suite VC10 AI-Rad Companion Organs RT | K252548 (2026) |
| XSTRAHL LIMITED Present in Europe in other categories | United Kingdom | Xstrahl Photoelectric Therapy System Xstrahl 300 X-Ray System - Floor Xstrahl 200 X-Ray System - Ceiling Xstrahl 150 X-Ray System Floor Xstrahl 100 X-Ray System Xstrahl 300 X-Ray System Ceiling | K230611 (2023) |
| Eckert & Ziegler Bebig GmbH Present in Europe in other categories | Germany | Custom AnchorMarker - Gold Marker preloaded in PSS1820SLS Round Hub Needle Preloaded in PSS1820SL3 Square Hub Needles, 3pk Preloaded in PSS1820SL3 Round Hub Needles, Single Pack Marker Seed - Preloaded in PSS1820SL3 Round Hub Needles, 3pk Marker Seed - Preloaded in PSS1820SL3 Round Hub Needles, Single Pack Custom MarkerStrand - Two Gold Marker preloaded in PSS1820SLS Round Hub Needle | registered |
| CONCURE ONCOLOGY, INC. | – | BMT Fiducial Needle, Sharp BMT Cleaning Brush Set, Vertical Lock BMT Armrest Armature & Table Clamp BMT Template Grid Armature & Table Clamp BMT Template Grid, Vertical Lock, Large BMT Fiducial Needle, Round | registered |
| Cp Medical | United States | FN NEEDLES | K071550 (2007) |
| Eckert & Ziegler Isotope Products, Inc. Present in Europe in other categories | – | Cs-137 Tube Source | registered |
| Radformation, Inc. Present in Europe in other categories | United States | ClearCalc EZFluence AutoContour | K262452 (2026) |
| .Decimal, LLC | United States | .decimal Proton Shell and Lid Assembly Decimal3D .decimal Astroid Planning App 3.x decimal Bolus (FlexiBol) .decimal Astroid Dosimetry App .decimal P.D | K211511 (2021) |
| Best Theratronics Ltd | Canada | GammaBeam Theratron | K150191 (2015) |
| CLEARSIGHT RT LLC | – | Clearsight Bolus | registered |
| Isoray Medical, Inc. | United States | GliaSite® Catheter Tray GliaSite® Access Tray Iotrex® Cesitrex™ | K202267 (2020) |
| MedCom Gesellschaft für medizinische Bildverarbeitung mbH Present in Europe in other categories | – | Prelude | registered |
| ARGON MEDICAL DEVICES, INC. | United States | Prostate Seeding Set Prostate Stabilization Set | registered |
| ASHLAND SPECIALTY INGREDIENTS G.P. Present in Europe in other categories | United States | Gafchromic™ FilmQA Pro | registered |
| Medscint Inc. | Canada | HYPERSCINT QA | registered |
| Our Smd Medical (Wuhan) Co., Ltd. | China | SMD-XGD/AR Galaxy SMD Galaxy RTx | registered |
| RESONANCE HEALTH ANALYSIS SERVICES PTY LTD | Australia | R2*/T2* Phantom T1CMR Phantom (3.0T) T1CMR Phantom (1.5T) T2CMR Phantom | registered |
| Sirtex Medical Inc. | United States | SIR-Spheres Delivery Set SIR-Spheres Accessories Pack SIROS Delivery Set SIR-Spheres V-Vial | registered |
| C4 Imaging, LLC | United States | HDR MRI Lumen Marker Sirius MRI Marker Sirius MRI Marker NS | K180069 (2018) |
| CLEAR GUIDE MEDICAL, INC. Present in Europe in other categories | United States | Clear Guide SteriGRID Clear Guide TP Access Posts | registered |
| Civatech Oncology, Inc. | United States | CivaSheet CivaString CivaDerm | K191324 (2019) |
| Cook, Inc. | United States | Cook | K940550 (1994) |
| GMV SOLUCIONES GLOBALES INTERNET SA | – | radiance | registered |
| Sensus Healthcare, Inc. Present in Europe in other categories | United States | Sensus | K182641 (2019) |
| Akesis, Inc. | United States | Galaxy RTi | K203146 (2021) |
| Barco N.V. Present in Europe in other categories | Belgium | QAWeb Enterprise | registered |
| Boston Scientific Corp Present in Europe in other categories | United States | TheraSphere™ | registered |
| CDR Systems Inc Present in Europe in other categories | Canada | Bolus - Gel (w/o Film) Bolus - Gel (film) | registered |
| Carina Medical LLC | United States | INTContour | K212274 (2022) |
| FUJIFILM Healthcare Americas Corporation Present in Europe in other categories | United States | D&K Technologies | registered |
| GE Medical Systems Present in Europe in other categories | United States | Quality Care Suite Auto Segmentation | K230082 (2023) |
| OrthoGrid Systems, Inc. | United States | OrthoGrid® | registered |
| Our United Corporation | China | CybeRay | K203250 (2021) |
| Permedics, Inc. | United States | Odyssey | K042861 (2005) |
| AngioDynamics, Inc. | United States | Alatus | registered |
| Coreline Soft Co., Ltd. Present in Europe in other categories | South Korea | AVIEW RT ACS | K220408 (2022) |
| Eizo Corporation Present in Europe in other categories | Japan | RadiCS | registered |
| Fujifilm Corporation Present in Europe in other categories | Japan | FCR 1Shot Phantom Plus | registered |
| GE Healthcare Present in Europe in other categories | United States | MR Contour DL | K242925 (2025) |
| Guangdong Meicen Medical Equipment Co., Ltd. Present in Europe in other categories | China | Meicen | registered |
| Hologic, Inc. Present in Europe in other categories | United States | Mammosite Cavity Evaluation Device Kit (CED) | K092405 (2009) |
| Lifeline Software, Inc. | United States | RadCalc® | K193381 (2019) |
| Lunit, Inc. Present in Europe in other categories | South Korea | Volpara Live | registered |
| Math Resolutions, LLC | United States | RtDosePlan | K022961 (2003) |
| MedMind Technology Co., Ltd. | China | RT-Mind-AI | K213155 (2021) |
| Neosoma, Inc. | United States | Neosoma Brain Mets | registered |
| Olympus Winter & Ibe GmbH Present in Europe in other categories | Germany | Olympus | registered |
| OncoSoft. co.,Ltd. | South Korea | OncoStudio | K260528 (2026) |
| Orthosoft, Inc. Present in Europe in other categories | Canada | X-Ray Marker 3D X-PSI | registered |
| RADIADYNE, L.L.C. | United States | Alatus | K092534 (2009) |
| REFLEXION MEDICAL, INC. | United States | Reflexion Medical Radiotherapy System | registered |
| SIRIS MEDICAL, INC. | United States | InsightRT CDS | K151560 (2015) |
| STANDARD IMAGING INC. Present in Europe in other categories | United States | Standard Imaging HDR 1000 Plus | registered |
| Sectra AB Present in Europe in other categories | United States | Sectra Calibration Unit | registered |
| Smith & Nephew, Inc. Present in Europe in other categories | United States | – | registered |
| The University of Texas M. D. Anderson Cancer Center | United States | Radiation Planning Assistant (RPA) | K222728 (2023) |
| Varian Medical Systems Finland Oy | – | Eclipse Treatment Planning System for External Beam Radiation Therapy | registered |
| Varian Medical Systems Imaging Laboratory GmbH | – | Smart Segmentation - Knowledge Based Contouring | registered |
| Vysioneer, Inc. | United States | VBrain | K213628 (2021) |
| Wisdom Technologies, Inc | China | DeepContour | K232928 (2024) |
| 3D Bolus, Inc. | Canada | – | K180289 (2018) |
| Accumetra | United States | – | registered |
| Agfa Corp. Present in Europe in other categories | United States | – | registered |
| Aitewan Biomedical Technology, Inc. | Taiwan | – | K252190 (2026) |
| Anatomical Geometry S.L. Present in Europe in other categories | Spain | – | K252784 (2026) |
| Anzai Medical Co., Ltd. | Japan | – | registered |
| Ashland Present in Europe in other categories | United States | – | registered |
| B.Braun Medical, Inc. Present in Europe in other categories | United States | – | registered |
| BBF Sterilisationsservice GmbH | Germany | – | registered |
The 100 most active manufacturers are shown, out of 184.
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- Parent category : Bioimaging and radiotherapy instruments589 manufacturers