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Toshiba America MRI, Inc.

United StatesFDA applicant, unverified

Devices
68

What Toshiba America MRI, Inc. makes

Toshiba America MRI produces magnetic resonance imaging (MRI) systems and associated coils, including flexible body coils, joint coils, cranio-cervical coils, and specialized software for MRI workflows. The portfolio includes MRI scanners like the MRT-50A and MRT-35-A, as well as accessories such as the OPART model MRT-600 and the FLEXART QD C-spine coil for targeted imaging applications.

These devices are classified as Class II under FDA regulations and are supported by 510(k) clearances. The company’s products are listed in the U.S. market, adhering to FDA requirements for MRI systems and peripheral components.

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

Catalogue68

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  • Opart, Model Mrt-600 Ref K991740

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

  • Mrt 50A Flexible Body Coil Ref K900285

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

  • Mrt-50 Ref K921413

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

  • Flexart V3.5 Software Ref K970573

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

  • Mrt 50A Joint Coil Ref K900727

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

  • Mrt 50A Ref K903770

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

  • Flexart(Tm) Qd C-Spine Coil Ref K945665

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

  • Mrt 50A Cranio-Cervical Coil Ref K900287

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

  • Mrt 35-A (Tm) Ref K905441

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

  • Opart, Model Mrt-600 Ref K000549

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

  • Access Ref K940796

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

  • Opart, Model Mrt-600 Ref K990007

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

  • Flexart Qd Body Coil Ref K944662

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

  • Mrt 50A 150mm Circular Surface Coil Ref K900284

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

  • Excelart With Pianissimo, Model Mrt-1501/P3 Ref K002531

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

  • Knee Qd Coil Mrt 50A Ref K902316

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

  • Mrt-50 Spine Coil Ref K920125

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

  • MRT35-Sp Ref K905442

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

  • Opart, Model Mrt-600 Ref K002522

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

  • Mrt-50GP Ref K933018

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

  • Mrt-35(Tm) Ref K921940

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

  • Mrt-50 Qd Head Coil Ref K920097

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

  • Access Magnetic Resonance Device Accessory Ref K930960

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

  • Access(Tm) Compass Bed Ref K946244

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

  • Advanced C- Spine Coil Ref K904327

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

  • Mrt-35A V9.0 Ref K964608

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

  • Mrt-50A, Mrt-150A Ref K926001

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

  • Mrt-50A Super Ref K924808

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

  • Magnetic Resonance Device Accessory, Sm Parts Coil Ref K910220

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

  • Opart Mrt-600 Ref K962933

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

  • Mrt 50A Software Release 9.0 Ref K900283

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

  • Mrt-50 Flexible Body Coil Ref K920126

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

  • Mrt-150A, Qd Spine Coil Ref K926171

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

  • Mrt-50A/150A Software Upgrade V12.0/12.1 Ref K961238

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

  • Extra Large Body Coil For Opart (Mrt-600) Ref K991057

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

  • Mrt-50 Qd Body Coil Ref K945875

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

  • Mrt-150 Qd Knee Coil Ref K920096

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

  • Opart/Prodiga, Opart/Protenza, Opart/Paragon Ref K993574

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

  • Excelart Ref K990620

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

  • Magnetic Resonance Device Accessory (Mrt-50A) Ref K911495

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

  • Magnetic Resonance Device Accessory Ref K911276

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

  • Flexart Tmj Coil Ref K961624

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

  • Mrt 50A Brain Qd Coil Ref K900288

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

  • Mrt-35A Upgrade 8.0CD Ref K945798

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

  • Mrt 50A 100mm Circular Surface Coil Ref K900289

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

  • Qd Whole Body Coil, Mrt-150A Ref K922798

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

  • Software Release 4.2P, Access(Tm) Ref K902310

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

  • Flexart Qd Head/Neck Coil Ref K961391

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

  • Mrt-50A Qd Spine Coil Ref K921720

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

  • Opart (Mrt-600) Versions 2 Software Upgrade Ref K981475

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

Rows 1-50 of 68

Showing 1-50 of 68

Frequently asked questions

How many devices does Toshiba America Mri, Inc. have in the registry?

The registry currently lists 68 devices for Toshiba America Mri, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Toshiba America Mri, Inc.'s devices?

Among its 50 most recently registered devices, Toshiba America Mri, Inc. has devices listed in FDA 510(k) (50 devices).

What risk classes do Toshiba America Mri, Inc.'s devices fall under?

Among its 50 most recently registered devices, the classes recorded for Toshiba America Mri, Inc.'s devices are Class II. Each device page shows its own class and authorisation.

What are the newest devices from Toshiba America Mri, Inc. in the registry?

The most recently registered devices listed for Toshiba America Mri, Inc. include OPART, MODEL MRT-600, MRT 50A FLEXIBLE BODY COIL, MRT-50 and FLEXART V3.5 SOFTWARE.

Generated automatically from registry data and not verified by a human reviewer.