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Resonex, Inc.

United StatesFDA applicant, unverified

Devices
22

What Resonex, Inc. makes

Resonex, Inc. manufactures magnetic resonance imaging (MRI) systems and associated software, including the mobile RX-4000 MRI system, 2D Time-of-Flight Magnetic Resonance Angiography (MRA) sequences, and specialized MRI coils such as bilateral TMJ coils and adjustable belt coils. Their portfolio also includes hardware components like power supplies, ECG gating units, and coil field extenders, as well as software applications like Kinematic MRI MovieMaker and Fast Spin Echo (FSE) imaging algorithms. Additional products include analog-to-digital converters (16-bit A/D) and coil systems compatible with RX4000 and RX5000 MRI platforms.

Resonex’s MRI-related devices are classified as Class II under FDA regulations, with some products authorised via 510(k) premarket notifications and others through Premarket Approval (PMA). These devices are listed in the FDA’s regulatory databases, and the company operates from the United States.

AI-generated from registry data, 2 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue22

Newest first, rows 1-22 of 22

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  • Version 4.3 Application Software For Use W/Rx-4000 Ref K901602

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

  • Bo Power Supply Ref K921046

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

  • Mobile Rx-4000 Magnetic Resonance Imaging System Ref K894974

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

  • 2DTOF Magnetic Resonance Angiograph (Mra) Ref K914114

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

  • Bilateral Tmj Coil Ref K902630

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

  • Ecg Gating Unit Ref K931392

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

  • Coil Field Extender Ref K911800

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

  • Coils For RX4000 & RX5000 Mri Systems Ref K920254

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

  • 16 Bit A/D Ref K915754

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

  • 10 Adjustable Belt Coil Ref K910269

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

  • Fast Spin Echo (Fse) Ref K935369

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

  • Kinematic Mri Moviemaker Ref K924154

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

  • Version 4.2 Application Software Ref K892959

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

  • 40-140 Spin Echo Flow Compensated Pulse Sequence Ref K913325

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

  • Magnetization Transfer Contrast Ref K922677

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

  • 3D Imaging Ref K923823

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

  • Rx-5000 Mri System Ref K911892

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

  • Noise Filter For Paradigm Magnetic Resonance Imaging System Ref K935570

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

  • 3DTOF Mra Ref K923870

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

  • Vfq Head Coil Ref K883737

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

  • Presaturation Ref K920835

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

  • Resonex RX4000{TM} Magnetic Resonance Imaging Syst Ref P860062

    Active Regimes: PMA Registry: PMA Class:II

Rows 1-22 of 22

Frequently asked questions

How many devices does Resonex, Inc. have in the registry?

The registry currently lists 22 devices for Resonex, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Resonex, Inc.'s devices?

Among its 22 most recently registered devices, Resonex, Inc. has devices listed in FDA 510(k) (21 devices) and FDA PMA (1 device). A device can be listed in more than one registry, so these counts overlap.

What risk classes do Resonex, Inc.'s devices fall under?

Among its 22 most recently registered devices, the classes recorded for Resonex, Inc.'s devices are Class II. Each device page shows its own class and authorisation.

What are the newest devices from Resonex, Inc. in the registry?

The most recently registered devices listed for Resonex, Inc. include VERSION 4.3 APPLICATION SOFTWARE FOR USE W/RX-4000, BO POWER SUPPLY, MOBILE RX-4000 MAGNETIC RESONANCE IMAGING SYSTEM and 2DTOF MAGNETIC RESONANCE ANGIOGRAPH (MRA).

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