Bioimaging and radiotherapy instrumentsEchography instruments
Ultrasound scanners
EMDN code Z110401
Manufacturers registered in Europe (EUDAMED) 92
- 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) 657
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 |
|---|---|---|---|
| CIVCO Medical Instruments Co., Inc. | United States | Needle Guide Biopsy Starter Kit Biopsy Bracket Verza Guidance System CIV-Flex™ Transducer Cover Needle Guide Starter Kit | K260114 (2026) |
| JingFang Precision Medical Device(Shenzhen) Co., Ltd. | China | InnoFine Mindray | registered |
| PARKS MEDICAL ELECTRONICS, INC. | United States | 8.2MHz SKNY PEN PROBE 10' 9.3MHZ PENCIL PROBE 841/842 8.2MHZ MICROVASCULAR PROBE 8.5MHZ ADULT FLAT PROBE 3.9MHz Pencil Probe 7 Foot ODU connector 9.1MHZ PENCIL PROBE 7' | registered |
| Protek Medical Products, Inc. | United States | Reusable Biopsy Bracket Sterile Disposable Endocavity Needle Guide Reusable Stainless Steel Endocavity Needle Guide Sterile Disposable Endocavity Needle Guide Kit Reusable Multi Angle Biospy Bracket Sterile Disposable Needle Guide | K973958 (1998) |
| Qingdao Hisense Medical Equipment Co., Ltd. | China | Hisense | K233841 (2024) |
| ADVANCE MEDICAL DESIGNS, INC. Present in Europe in other categories | United States | Ultrasound Probe Cover Biopsy Needle Guide Ultrasound Probe Cover Biopsy Needle Guide Kit UNBRANDED Soft Flex Probe Cover Rolled Probe Cover Probe Cover | K223689 (2023) |
| COMPUMEDICS LIMITED Present in Europe in other categories | Australia | DiaMon Fixation LAM Fixation Carotid surgery LAM Fixation Mandibula LAM Fixation Standard Headband Fixation L/XL Headband Fixation XS/S/M | registered |
| Medistim ASA Present in Europe in other categories | Norway | Medistim System Activation Card Medistim MiraQ Vascular System Medistim MiraQ Cardiac System Medistim MiraQ Ultimate System Medistim Vascular TTFM probe Medistim QuickFIT TTFM probe | registered |
| MEDTRONIC XOMED, INC. Present in Europe in other categories | United States | NIM-ECLIPSE® NIM Eclipse NIM-ECLIPSE | registered |
| Boston Scientific Corp Present in Europe in other categories | United States | AVVIGO™+ AVVIGO™ Guidance System II MDU5 PLUS iNod™ iNod™ Ultrasound Guidance Conso Ultra ICE Plus | K260816 (2026) |
| Eko Devices, Inc. | United States | CORE 500 Digital Stethoscope - Sapphire Chestpiece CORE 500 Digital Stethoscope FIGS Earpiece - Caribbean Blue CORE 500 Digital Stethoscope - Navy Blue Bundle CORE 500 Digital Stethoscope FIGS Earpiece - Orange Taffy CORE 500 Digital Stethoscope - Champagne Bundle CORE 500 Digital Stethoscope - Champagne Earpiece | K230111 (2023) |
| Koven Technology, Inc. Present in Europe in other categories | United States | NP Probe CRP Probe HP Probe NRP Probe NDP Probe VRP Probe | K153762 (2016) |
| OWENS & MINOR DISTRIBUTION, INC. | – | HALYARD | registered |
| Wuxi Hisky Medical Technologies Co., Ltd. Present in Europe in other categories | China | Shear Wave Quantificational Ultrasound Diagnostic System Imaging Probe Fibrosis Scanning Probe | K250026 (2025) |
| Biim Ultrasound AS | Norway | Biim Android App, P1.3.2 Biim Android App, P1.1 Probe holder, (V2) Biim Ultrasound Biim Ultrasound L12-4 Linear Array Transducer Biim iOS App, P1.1 Probe Holder, (V1) Biim Ultrasound | K173138 (2017) |
| TELEMED UAB | – | ArtUs MicrUs SmartUs MicrUs Pro | registered |
| GE PARALLEL DESIGN, INC. Present in Europe in other categories | – | – | registered |
| Endosound, Inc. | United States | EndoSound® EVS™ Band Applicator EndoSound® EVSScanner EndoSound® EVS™ Bands EndoSound® Transducer Extension Connector (TEC) EndoSound® Coax Transducer Extension Connector (TEC) EndoSound® Ultrasound Disposable Kit (UDK-T) 5008 | K232518 (2023) |
| Eco-Med Pharmaceutical Inc | – | Ecogel 200 EcoLotion Ecogel 100 EcoGel 200 Clear | registered |
| HOYA CORPORATION | United States | PENTAX PENTAX Medical | registered |
| NEXT MEDICAL PRODUCTS, LLC | United States | Clear Image Clear Image Singles Novaplus LithoClear Clear Image Singles Lite ClearWave | registered |
| EXACT MEDICAL MANUFACTURING, INC. | China | Exact Medical Manufacturing, Inc. Proficient Surgical | K222460 (2023) |
| PARALLEL DESIGN Present in Europe in other categories | – | – | registered |
| Ellex Medical Pty, Ltd. Present in Europe in other categories | Australia | Ellex Eye Cubed V4 New Gen 40MHZKIT-USA ACC00042 | K190786 (2019) |
| MedXPress.Pro Present in Europe in other categories | Belgium | EZCOVER® STOP Gel-Free EZCOVER® Gel-Free EZCOVER® Gel-Vision EZCOVER® STOP Gel-Vision | K191491 (2020) |
| TELEFLEX INCORPORATED Present in Europe in other categories | United States | SMARTNEEDLE ARROW | registered |
| Accutome, Inc. | United States | B-scan Pro: Software Package B-scan Pro- VET A-scan Plus Connect B-scan Plus 4Sight B-scan Pro | K152573 (2015) |
| Verathon Incorporated Present in Europe in other categories | United States | BladderScan® ScanPoint® | K172356 (2017) |
| ASPEN SURGICAL PRODUCTS, INC. Present in Europe in other categories | United States | Bovie | registered |
| GEOTEK MEDIKAL VE SAGLIK HIZMETLERI TICARET SANAYI LIMITED SIRKETI | – | GTK Disposable Needle Guides | registered |
| HUMANSCAN CO., LTD Present in Europe in other categories | United States | HUMANSCAN | K083824 (2009) |
| Ulthera, Inc. | – | Ulthera System Transducer Ulthera System Control Unit Ulthera System Handpiece Ulthera System Control Unit PRIME Ulthera System | registered |
| C.R. Bard, Inc. | United States | Sure-Point™ Brachy Needle Template Siemens Brachy Needle Template B-K Brachy Probe Cradle B-K 8848 Brachy Probe Cradle GE ERB Brachy Needle Box | K182281 (2018) |
| Novasignal Corp. | United States | NovaGuide™ 2 Traditional Ultrasound System NovaGuide™ Intelligent Ultrasound System NovaKit™ 2 Exam Pack NovaGuide™ 2 Intelligent Ultrasound System 2-MHz Transducer, Handheld Remote Control Accessory | K213279 (2022) |
| Kolo Medical (Suzhou) Co., Ltd. | China | KOLO | K221568 (2022) |
| Analogic Corp. | United States | Sonic Window Sterile Transducer Cover Sonic Window Handheld Ultrasound System Sonic Window Handheld Ultrasound Unit Sonic Window Docking Station Pathfinder Large Multi-Tool Instrument Clamp Pathfinder Long Probe | K161342 (2016) |
| Esi, Inc. | United States | Prager Shell® PRAGER SHELL® P106SVGS ClearScan® | K082893 (2008) |
| Micro-Tech (Nanjing) Co., Ltd. | China | Areus(TM) Endoscopic Ultrasound Aspiration Needle (FNA) Areus(TM) Adapt Endoscopic Ultrasound Aspiration Needle(FNA) Trident(TM) Adapt Endoscopic Ultrasound Biopsy Needle(FNB) | K212852 (2021) |
| Acist Medical Systems, Inc. Present in Europe in other categories | United States | ACIST HDi® Power Supply ACIST HDi® HD IVUS System ACIST HDi® System Console ACIST HDi® Linear Translation System (LTS) ACIST HDi® Cart ACIST HDi™ Cart | K193183 (2020) |
| Parker Laboratories, Inc. Present in Europe in other categories | United States | POLYSONIC Aquaflex ECLIPSE STERILE AQUASONIC Delphinus Sequr™ Parker Labs | K233965 (2024) |
| THD SPA Present in Europe in other categories | Italy | THD Procto Software System | K211623 (2021) |
| ACESSA HEALTH INC. | – | Acessa ProVu Handpiece Acessa Pads Acessa ProVu Handpiece Cable Acessa ProVu Planar Field Generator (PFG) Acessa Pad Cable Acessa ProVu PFG Table Clamp | registered |
| Avante | – | Crystal 4P FS-60 Advance FS-32P | registered |
| TYTO CARE LTD Present in Europe in other categories | Israel | TytoHome Tyto Stethoscope TytoPro Not in use | K252089 (2026) |
| Conavi Medical Inc | Canada | Foresight ICE™ PIM Foresight ICE™ Catheter Foresight ICE™ Hummingbird Console Foresight ICE™ Catheter Accessories Package Novasight Hybrid™ Catheter Novasight Hybrid™ Hummingbird Console | K252945 (2026) |
| Suzhou PeakSonic Medical Technology Co.,LTD. Present in Europe in other categories | China | Bladder Scanner | K213488 (2022) |
| Nidek, Inc. Present in Europe in other categories | United States | A-scan probe ECHOSCAN Pachymetry probe Pachymetry probe (45° fixed type) OPTICAL BIOMETER | K020876 (2002) |
| Pentax of America, Inc. Present in Europe in other categories | United States | ULTRASOUND GASTROSCOPE NOBLUS PREIRUS ENDOPRO IQ | K203166 (2020) |
| American Diagnostic Corp. Present in Europe in other categories | United States | Adscope® | K162589 (2017) |
| CLEAR GUIDE MEDICAL, INC. Present in Europe in other categories | United States | Clear Guide SteriGRID Clear Guide SCENERGY TP Clear Guide TP Access Tool Clear Guide TP Access Frame Clear Guide TP Access Posts Clear Guide Optical Head | K141806 (2014) |
| DEVICOR MEDICAL PRODUCTS, INC. Present in Europe in other categories | United States | Mammotome Mammotome revolve Mammotome MammoTest | registered |
| Mcube Technology Co., Ltd. Present in Europe in other categories | South Korea | CUBEscan | K201995 (2020) |
| PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE | – | Morpheus® Quickscan Morpheus Pathway® | registered |
| MEDLINE INDUSTRIES, INC. Present in Europe in other categories | United States | Medline | registered |
| NATUS NEUROLOGY INCORPORATED Present in Europe in other categories | United States | Natus NATUS NEUROLOGY | registered |
| Biosense Webster, Inc. Present in Europe in other categories | United States | SOUNDSTAR NUVISION NAV Ultrasound Catheter NUVISION Ultrasound Catheter SOUNDSTAR CRYSTAL Ultrasound Catheter NuVision ICE Catheter NuVision Connector Cable | K241540 (2024) |
| Cardinal Health 200, LLC Present in Europe in other categories | United States | CARDINAL HEALTH | registered |
| Laborie Medical Technologies Canada ULC | – | NuWav | registered |
| U.S. OPHTHALMIC, L.L.C. | United States | Gilras Eli Ezer | registered |
| Echosens Present in Europe in other categories | France | FibroScan | K223902 (2023) |
| MCKESSON MEDICAL-SURGICAL INC. | – | McKesson | registered |
| Mendaera, Inc. | United States | Focalist System Software Focalist System Focalist Robot Drape Kit Focalist Probe and Robot Drape Kit Mendaera Robot Drape Kit Mendaera Probe and Robot Drape Kit | K250524 (2025) |
| Provisio Medical, Inc. | United States | SLT IVUS P1 Display Unit SLT IVUS P1 Pulser Receiver Unit SLT IVUS P1 Cart SLT IVUS Support Crossing Catheter | K233948 (2024) |
| RIMED LTD. | Israel | Digi-Lite IP Digi-One Digi-Lite CW 8MHz Ultrasonic Probe Digi-Lite IP Linear Probe PW 2MHz Ultrasonic Probe | K143476 (2015) |
| TIDI PRODUCTS, LLC | United States | TIDIShield Medi-Inn Abbott Medical | registered |
| Analog Devices, Inc. | United States | SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM) SENSINEL™ CPM BASE STATION SENSINEL™ CPM WEARABLE SENSINEL™ CPM ALIGNMENT TOOL SENSINEL™ CPM REPLACEMENT ADHESIVE PAD SENSINEL™ CPM REPLACEMENT ADHESIVES (15 Pack) | registered |
| Best Nomos | United States | Sonalis TargetScan Touch Needle Kit, TargetScan 3, 18 Gauge, 5 Pack Needle Kit, TargetScan 2, 18 Gauge, Single Needle Kit, TargetScan 2, 18 Gauge, 5 Pack Needle Kit, TargetScan 3, 18 Gauge, Single | registered |
| CorVascular | – | VasoGuard | registered |
| Gynesonics, Inc. Present in Europe in other categories | United States | Sonata® Sonography-Guided Transcervical Fibroid Ablation System Sonata® Intrauterine Ultrasound Probe Sonata® IUUS Probe Sterile Shipper Kit Sonata® IUUS Probe Connector Protector Sonata® Intrauterine Ultrasound Probe Return Kit Sonata® System Cart | K061153 (2006) |
| Halo Medical Technologies, LLC | United States | Halo Medical Technologies Halo Med. Technologies | K140899 (2014) |
| Huntleigh Healthcare, Inc. | United Kingdom | DOPPLEX | K201425 (2021) |
| Nipro Vascular Innovations Americas, Inc. | United States | Makoto Intravascular Imaging System™ Dualpro™ IVUS+NIRS Imaging Catheter Kit Makoto Integrated Intravascular Imaging System™ TVC Controller Sterile Barrier TVC Imaging System™ Infraredx Clarispro™ HD-IVUS Imaging Catheter Kit | registered |
| Rnk Products, Inc. | United States | RNK Products | K132405 (2013) |
| Volcano Corporation | United States | R-100 CORE Series Precision Guided Therapy System CORE M2 Vascular System ComboMap Pressure and Flow System s5i Imaging System Workstation S5 IMAGING SYSTEM P/N 807300001 | K203719 (2021) |
| Aesthetics Biomedical, Inc. | United States | VIVACE ULTRA | registered |
| Beijing East Whale Imaging Technology Co., Ltd. | China | WHALE | K160343 (2016) |
| Carbon (Shenzhen) Medical Device Co., Ltd. | China | CarbonMed | K243298 (2025) |
| G E MEDICAL SYSTEMS ISRAEL LTD. | Israel | Vivid 830 to 860 Upgrade | K142323 (2014) |
| Globalmed Holdings, LLC | United States | ClearProbe ClearSteth | registered |
| Red Medical Supplies Ltd | – | RED Medical Supplies | registered |
| Siemens Healthcare GmbH Present in Europe in other categories | Germany | AI-Rad Companion (Pulmonary) AI-Rad Companion Brain MR syngo Application Software Ai-Rad Companion Prostate MR syngo.CT Coronary Cockpit | K253689 (2026) |
| ADVANCED INSTRUMENTATIONS, INC. | United States | ADVANCED ULTRASOUND | K172931 (2017) |
| Astrasono technology co.,ltd. | China | Astrasono A3Essential Bladder Scanner Astrasono A5Pro Bladder Scanner Astrasono A3Pro Bladder Scanner Astrasono A3Pro Lite Bladder Scanner | K250331 (2025) |
| Biobot Surgical Pte., Ltd. Present in Europe in other categories | Singapore | iSR'obot Mona Lisa iSR'obot Kit iSR'obot Biopsy Kit | K232320 (2023) |
| Brainlab AG Present in Europe in other categories | Germany | TraumaCad Neo Brainlab Elements BOLD MRI Mapping Image Fusion Fibertracking Contouring Brainlab Elements Image Fusion | K243633 (2025) |
| EMAGINE SOLUTIONS TECHNOLOGY LLC | United States | VistaScan™ | K192170 (2020) |
| Kiltex Corporation | United States | Kiltex Corporation Kiltex Corpoartion | K961029 (1996) |
| Brainomix Limited Present in Europe in other categories | United Kingdom | Brainomix 360 e-CTA e-CTA | K260406 (2026) |
| GuangDong Youkey Medical Co., Ltd. | China | – | K231930 (2024) |
| LINKQUEST INC. | United States | LinkQuest Diagnostic Ultrasound System and Transducers Phase Array Linear Array Convex 3D Array Convex Array MicroConvex Array | K172059 (2017) |
| ULTRAVISION CORPORATION | United States | UltraVision | registered |
| ADVANCED ECHO TECHNOLOGY Present in Europe in other categories | – | MELODY | registered |
| Alcon Laboratories, Inc. Present in Europe in other categories | United States | Alcon | registered |
| Caresono Technology Co.,Ltd. | Taiwan | Caresono | K153581 (2016) |
| Drive Devilbiss Healthcare | United States | Roscoe Medical LG | registered |
| Edge Life Technologies, LLC | United States | EdgeLife Technologies | K234153 (2024) |
| Exo Imaging, Inc. | United States | Exo Iris Exo Iris Ultrasound System | K260217 (2026) |
| Fukuda Denshi USA, Inc. Present in Europe in other categories | United States | FUKUDA DENSHI | K110920 (2011) |
| Imbio, LLC | United States | Imbio RV/LV Imbio PHA | K241847 (2024) |
| MEDTRONIC SOFAMOR DANEK, INC. Present in Europe in other categories | United States | NIM-Eclipse NIM-ECLIPSE® | registered |
The 100 most active manufacturers are shown, out of 657.
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