Bioimaging and radiotherapy instruments
Echography instruments
EMDN code Z1104
Manufacturers registered in Europe (EUDAMED) 100
- 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) 707
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 CIV-Flex™ Transducer Cover Needle Guide Starter Kit Transducer Cover Biopsy Bracket | K260114 (2026) |
| JingFang Precision Medical Device(Shenzhen) Co., Ltd. | China | InnoFine Mindray | 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) |
| 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) |
| PARKS MEDICAL ELECTRONICS, INC. | United States | 811-BL 24V FOREIGN & DOMESTIC POCKET DOPPLER MODEL 841-A VAS./OB DOPPLER MODEL 917 24V POCKET DOPPLER MODEL 840 DOPPLER 811-BTS 24V IN 901 C/C DOPPLER 811-BTS 24V IN 800 C/C | registered |
| Qingdao Hisense Medical Equipment Co., Ltd. | China | Hisense | K233841 (2024) |
| Sheathing Technologies, Inc. Present in Europe in other categories | United States | Sheathes Sheathes3D SheathesISO Vital Care Industries SheathesGel | K153212 (2016) |
| Transonic Systems, Inc. Present in Europe in other categories | United States | Transonic | K261714 (2026) |
| 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) |
| 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 |
| OWENS & MINOR DISTRIBUTION, INC. | – | HALYARD Medichoice | registered |
| Eco-Med Pharmaceutical Inc | – | Ecogel 200 EcoLotion Ecogel 100 EcoGel 200 Clear | registered |
| TELEMED UAB | – | ArtUs MicrUs SmartUs MicrUs Pro | registered |
| EXACT MEDICAL MANUFACTURING, INC. | China | Exact Medical Manufacturing, Inc. Proficient Surgical | K222460 (2023) |
| 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) |
| 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) |
| 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) |
| 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 |
| 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) |
| HOYA CORPORATION | United States | PENTAX PENTAX Medical | 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) |
| Ellex Medical Pty, Ltd. Present in Europe in other categories | Australia | Ellex Eye Cubed V4 New Gen 40MHZKIT-USA ACC00042 | K190786 (2019) |
| NEWMAN MEDICAL LLC | United States | DigiDop simpleABI | K110628 (2011) |
| 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) |
| Endosound, Inc. | United States | EndoSound® Ultrasound Transducer Module (UTM) EndoSound® EVS Probe EndoSound® EVS™ Band Applicator EndoSound® EVSScanner EndoSound® EVS™ Bands EndoSound® Transducer Extension Connector (TEC) | K232518 (2023) |
| NATUS NEUROLOGY INCORPORATED Present in Europe in other categories | United States | NATUS NEUROLOGY Natus NATUS NEUROLOGY INCORPORATED | registered |
| National Therapy Products Inc | Canada | Sonicshield Wavelength | K013212 (2002) |
| Esi, Inc. | United States | Prager Shell® PRAGER SHELL® P106SVGS ClearScan® | K082893 (2008) |
| NEXT MEDICAL PRODUCTS, LLC | United States | Clear Image Clear Image Singles Novaplus LithoClear Clear Image Singles Lite ClearWave | registered |
| TELEFLEX INCORPORATED Present in Europe in other categories | United States | SMARTNEEDLE ARROW | registered |
| Verathon Incorporated Present in Europe in other categories | United States | BladderScan® ScanPoint® | K172356 (2017) |
| MCKESSON MEDICAL-SURGICAL INC. | – | McKesson | registered |
| Novasignal Corp. | United States | 2-MHz Transducer, Handheld NovaGuide™ 2 Traditional Ultrasound System Remote Control Accessory 2Mhz Monitoring Transducer - 8 foot NovaGuide™ Intelligent Ultrasound System Temporal Monitoring Headframe | K213279 (2022) |
| Analogic Corp. | United States | Pathfinder Large Multi-Tool Instrument Clamp Sonic Window Sterile Transducer Cover Pathfinder Long Probe Sonic Window Handheld Ultrasound System Pathfinder Shadow Sonic Window Handheld Ultrasound Unit | K161342 (2016) |
| Avante | – | E-ST E-ST Pro Compact II Crystal 4P FS-60 Advance FS-32P | registered |
| MEDLINE INDUSTRIES, INC. Present in Europe in other categories | United States | Medline MEDLINE INDUSTRIES, INC. | registered |
| Huntleigh Healthcare, Inc. | United Kingdom | DOPPLEX | K201425 (2021) |
| Kolo Medical (Suzhou) Co., Ltd. | China | KOLO | K221568 (2022) |
| Cardinal Health 200, LLC Present in Europe in other categories | United States | CARDINAL HEALTH | registered |
| Pharmaceutical Innovations, Inc. | United States | Pharmaceutical Innovations | K163026 (2018) |
| Ulthera, Inc. | – | Ulthera System Transducer Ulthera System Control Unit Ulthera System Handpiece Ulthera System Control Unit PRIME Ulthera System | registered |
| 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 |
| Suzhou PeakSonic Medical Technology Co.,LTD. Present in Europe in other categories | China | Bladder Scanner | K213488 (2022) |
| CLEAR GUIDE MEDICAL, INC. Present in Europe in other categories | United States | Clear Guide SteriGRID Clear Guide SCENERGY TP Clear Guide TP Access Frame Clear Guide TP Access Posts Clear Guide TP Access Tool Clear Guide Optical Head | K141806 (2014) |
| 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) |
| Mcube Technology Co., Ltd. Present in Europe in other categories | South Korea | CUBEscan | K201995 (2020) |
| 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) |
| PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE | – | Morpheus® Quickscan Morpheus Pathway® | registered |
| 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) |
| 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) |
| Laborie Medical Technologies Canada ULC | – | NuWav | registered |
| Parker Laboratories, Inc. Present in Europe in other categories | United States | POLYSONIC Aquaflex ECLIPSE STERILE AQUASONIC Delphinus Sequr™ Parker Labs | K233965 (2024) |
| RIMED LTD. | Israel | CW 8MHz Ultrasonic Probe Digi-One Digi-Lite IP Linear Probe PW 2MHz Ultrasonic Probe CW 4MHz Ultrasonic Probe Digi-Lite IP | K143476 (2015) |
| Red Medical Supplies Ltd | – | RED Medical Supplies | registered |
| U.S. OPHTHALMIC, L.L.C. | United States | Gilras Eli Ezer | registered |
| TYTO CARE LTD Present in Europe in other categories | Israel | TytoHome Tyto Stethoscope TytoPro Not in use | K252089 (2026) |
| Best Nomos | United States | Sonalis 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 TargetScan Touch | registered |
| Pentax of America, Inc. Present in Europe in other categories | United States | ULTRASOUND GASTROSCOPE NOBLUS PREIRUS ENDOPRO IQ | K203166 (2020) |
| Biobot Surgical Pte., Ltd. Present in Europe in other categories | Singapore | iSR'obot Mona Lisa iSR'obot Kit iSR'obot Biopsy Kit | K232320 (2023) |
| 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) |
| American Diagnostic Corp. Present in Europe in other categories | United States | Adscope® | K162589 (2017) |
| DEVICOR MEDICAL PRODUCTS, INC. Present in Europe in other categories | United States | Mammotome Mammotome revolve Mammotome MammoTest | registered |
| Drive Devilbiss Healthcare | United States | Roscoe Medical LG GelShot | registered |
| Echosens Present in Europe in other categories | France | FibroScan | K223902 (2023) |
| GuangDong Youkey Medical Co., Ltd. | China | – | K231930 (2024) |
| ADVANCED INSTRUMENTATIONS, INC. | United States | ADVANCED POCKET DOPPLER ADVANCED ULTRASOUND | K172931 (2017) |
| Globalmed Holdings, LLC | United States | ClearProbe ClearSteth | registered |
| PRESTIGE AMERITECH, LTD. | United States | PremierPro | registered |
| Perimed AB | United States | PH 07-4 Tape-Fixated Probe Holder PH 07-5 Small Tape-Fixated Probe Holder PROBE 457 Small Angled Thermostatic Probe PeriFlux 6000 PeriCam PSI NR PF 6050 Pressure Unit | K152930 (2016) |
| SYNOVIS MICRO COMPANIES ALLIANCE, INC | United States | GEM FLOW COUPLER GEM FLOW COUPLER External Lead GEM FLOW COUPLER AC Power Supply Kit, US GEM FLOW COUPLER Monitor GEM FLOW NOW | K233394 (2024) |
| St Jude Medical | United States | ViewFlex™ ViewMate™ AptiVue™ | K121381 (2012) |
| Astrasono technology co.,ltd. | China | Astrasono A3Essential Bladder Scanner Astrasono A5Pro Bladder Scanner Astrasono A3Pro Bladder Scanner Astrasono A3Pro Lite Bladder Scanner | K250331 (2025) |
| Beijing East Whale Imaging Technology Co., Ltd. | China | WHALE | K160343 (2016) |
| 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) |
| Carbon (Shenzhen) Medical Device Co., Ltd. | China | CarbonMed | K243298 (2025) |
| Dgh Technology, Inc. Present in Europe in other categories | United States | UBM 35 MHz Transducer 20 MHz B-Scan Probe Scanmate Flex USB Interface DGH 2006 Corded Pachymeter Probe UBM Probe DGH 6006 Corded A-Scan Probe | registered |
| EMAGINE SOLUTIONS TECHNOLOGY LLC | United States | VistaScan™ | K192170 (2020) |
| G E MEDICAL SYSTEMS ISRAEL LTD. | Israel | Vivid 830 to 860 Upgrade | K142323 (2014) |
| HR PHARMACEUTICALS INC. | United States | EcoVue EcoVue HV HR Ultrasound Jelly | K181363 (2018) |
| LINKQUEST INC. | United States | Phase Array Linear Array Convex 3D Array Convex Array MicroConvex Array LinkQuest Diagnostic Ultrasound System and Transducers | K172059 (2017) |
| TIDI PRODUCTS, LLC | United States | TIDIShield Medi-Inn Abbott Medical | registered |
| 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) |
| 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 |
| CorVascular | – | VasoGuard | registered |
| HENRY SCHEIN, INC. Present in Europe in other categories | United States | Henry Schein | registered |
| Halo Medical Technologies, LLC | United States | Halo Medical Technologies Halo Med. Technologies | K140899 (2014) |
| IMEX, LLC | United States | Imex ELITE 8MHZ VASCULAR PROBE Imex CT+ Doppler Imex Elite 100 Doppler Imex ELITE 2MHZ WATERPROOF PROBE V2 Imex Elite 200 Doppler Elite 5 MHz Vascular Probe | registered |
| MARKETLAB INC. | United States | Marketlab, Inc | registered |
| Mettler Electronics Corp. | United States | Sonigel Ultrasound Gel Couplants Sonigel Lotion with Aloe Vera | registered |
| 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) |
| ULTRAVISION CORPORATION | United States | UltraVision | registered |
| US Endoscopy | United States | Ultramatrix Oracle | registered |
| Aesthetics Biomedical, Inc. | United States | VIVACE ULTRA | registered |
| Alcon Laboratories, Inc. Present in Europe in other categories | United States | Alcon | registered |
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