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Innovative Magnetic Resonance Imaging Systems, Inc.

United StatesFDA applicant, unverified

Devices
2
FDA recalls
1

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Innovative Magnetic Resonance Imaging Systems, Inc. makes

The company manufactures magnetic resonance imaging (MRI) systems, including the NEURO II and NEURO II-S models, designed for specialized neurological imaging applications.

These devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue2

Newest first, rows 1-2 of 2

  • Neuro Ii Ref K002964

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

  • Neuro Ii-S Ref K050132

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

FDA recalls1

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

FDA recall records list 1 recall initiated by Innovative Magnetic Resonance Imaging Systems, Inc., initiated on 2012-10-19. By recorded status: 1 terminated. The reasons filed fall into these groups: other reasons as filed. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

  • 2012

    • 19 Oct 2012 Z-0428-2013 Class II Terminated IMRIS Inc. initiated a recall of their OR Tables ORT100 and ORT200. When proper procedure is not followed, the foot end of the IMRIS intra-operative OR table may be attracted to the MRI magnet as the magnet approaches the table. This poses a potential risk of injury to both the patient and operators standing near the table. Distribution: Nationwide Distribution, including the states of FL, GA, IN, MD,MA, MI, MN, MO, TN, UT, and VA. Submission numbers: K061916, K071099, K083137

Frequently asked questions

How many devices does Innovative Magnetic Resonance Imaging Systems, Inc. have in the registry?

The registry currently lists 2 devices for Innovative Magnetic Resonance Imaging Systems, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Innovative Magnetic Resonance Imaging Systems, Inc.'s devices?

Among its 2 most recently registered devices, Innovative Magnetic Resonance Imaging Systems, Inc. has devices listed in FDA 510(k) (2 devices).

What risk classes do Innovative Magnetic Resonance Imaging Systems, Inc.'s devices fall under?

Among its 2 most recently registered devices, the classes recorded for Innovative Magnetic Resonance Imaging Systems, Inc.'s devices are Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Innovative Magnetic Resonance Imaging Systems, Inc.?

FDA recall records list 1 recall initiated by Innovative Magnetic Resonance Imaging Systems, Inc., the most recent initiated on 19 Oct 2012. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Innovative Magnetic Resonance Imaging Systems, Inc. in the registry?

The most recently registered devices listed for Innovative Magnetic Resonance Imaging Systems, Inc. include NEURO II and NEURO II-S.

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