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Elscint, Inc.

United StatesFDA applicant, unverified

Devices
94

What Elscint, Inc. makes

Elscint, Inc. manufactures magnetic resonance imaging (MRI) systems, including the Gyrex 2T Prestige, Gyrex Privilege, and Gyrex 2T-DLX models, along with compatible head and neck coils. The company also produces diagnostic ultrasound imaging equipment, such as the Dynex-44 and SDL-100A models, as well as computed tomography (CT) scanners like the Exel 2400E and Excel CT Twin. Additionally, it supplies mammography systems, including the Mam LS-3 microfocus mammography system with magnification capabilities.

The company’s portfolio includes devices classified under FDA’s Class I and Class II categories, with regulatory submissions recorded in the FDA’s 510(k) and PMA registries. These products are listed under U.S. jurisdiction, reflecting compliance with U.S. medical device regulations.

AI-generated from registry data, 3 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue94

Newest first, rows 51-94 of 94

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  • Xrt-7.0 Ref K964583

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Hi-Lo Radiological Stretcher Ref K837183

    Active Regimes: 510(k) Registry: 510(k) Class:—

  • Extended Obstetrics Software Computation Package Ref K890637

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Biopsy Needle Guide Attachment Ref K890327

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Esi-1002 System And DC100S/C50M-P Transducer Ref K870964

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • The Esi-2000 Ultrasound Unit Ref K874683

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Trephix Three Phse Generators And Exonon Single Phase Generators Ref K837180

    Active Regimes: 510(k) Registry: 510(k) Class:—

  • Ecg Module Ref K862553

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Exel 2002 & 2002FS Ct Scanner Ref K884669

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Select/Sp Ref K961464

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Volume Neck Coil For The Gyrex V-Dix Ref K935224

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Apex Helix - A Ref K914807

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Advanced Automatic Kv Ref K934831

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Cp-Spine Coils For Gyrex 2T-Dlx & V-Dlx Ref K934987

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Apex 115 Nuclear Medicine Processor Ref K884672

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Aviva Mammographic X-Ray System Ref K915748

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Additional Features Esi-3000 Ultrasound Unit Ref K925627

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Armex Ls-51 Ref K837175

    Active Regimes: 510(k) Registry: 510(k) Class:—

  • Exel 1002 Ct Scanner Ref K884668

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Volumax Ct Imaging System Ref K982060

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Exel 905 Series Ct Scanner Ref K884667

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Volmetric Coincidence Detection System Ref K962100

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • 3D Processing Options For Gyrex Ref K915579

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Exel 1800 And 1800E Ct Scanner Ref K884670

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Hrsw Option For Ct Twin Flash Ref K945512

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Apex 215M Mobile Anger Camera Ref K884673

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Tomax Ls-20 Ref K837182

    Active Regimes: 510(k) Registry: 510(k) Class:—

  • Gyrex 2T-Prestige Ref K970005

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Floatex Ls-22 Ref K837353

    Active Regimes: 510(k) Registry: 510(k) Class:—

  • Transvaginal Probe, Model ED65M-Tv Ref K861371

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Quantem Ref K963162

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Taurus Ls Three-Phase Generators Ref K837179

    Active Regimes: 510(k) Registry: 510(k) Class:—

  • Esi-3000 Ultrasound System Ref K904359

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Gyrex V-Ep Ref K962618

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Aviva F22/Mam-CH22 W/Optional Cytoguide Biopsy Sys Ref K930282

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Glory Ref K970680

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Standex System Ref K837178

    Active Regimes: 510(k) Registry: 510(k) Class:—

  • Controllex Ls-5 Ref K837177

    Active Regimes: 510(k) Registry: 510(k) Class:—

  • Varicam Ref K953801 Open recall

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Biopsy Needle Guide Attachment Ref K863797

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Cardiac Computation Software Package Ref K890636

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Special Purpose Coils For Gyrex V Ref K915598

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Angioct Option For Ct-Twin, Helicat & Omniview Ref K932508

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Gyrex Ref P840007

    Active Regimes: PMA Registry: PMA Class:II

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