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Imris, Inc.

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Devices
14
FDA recalls
1

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

Catalogue14

Newest first, rows 1-14 of 14

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  • SYMBIS Surgical System Ref K143420

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

  • HFD100 Rocker Arm Accessory Ref K141950

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

  • Neuro Ii-Se, Models Or-Mb-Dr And Or-Dr Ref K061916

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

  • Ict Ref K130224

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

  • Imrx Ref K091166

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

  • Imrx System V1 And Imrisnv/Imriscardio Ref K101813 Open recall

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

  • Neuro Iii-Sv Ref K083137 Open recall

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

  • Visius Wireless Coils, 1.5T/ Visius Wireless Coils, 3T Ref K123091

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

  • Imris Oncology Package Ref K121997

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

  • 1.5T Head Coil (HC150), 3T Head Coil (HC300) Ref K103506

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

  • Imris Mr/X-Ray Head Fixation Device (Hfd) Ref K113748

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

  • Head Fiation Device (Hfd 100) Ref K103493 Open recall

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

  • Neuro Ii-Se, Models: Or-Dr-Or, Or-Mb Ref K071099

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

  • Imri 1.5T And Imri 3T S Ref K133692 Open recall

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

Rows 1-14 of 14

FDA recalls1

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

  • 2014

    • 1 Oct 2014 Z-0144-2015 Class II Terminated One of the three pins that is used to hold the ORT200 table alignment block in place on the floor of the MR Suite went missing during testing at a health care facility. Distribution: Worldwide Distribution -- USA, including the states of CA, FL, NH, NC, TN, and UT; and, the countries of AUSTRALIA,…
      Full distribution text Worldwide Distribution -- USA, including the states of CA, FL, NH, NC, TN, and UT; and, the countries of AUSTRALIA, CANADA, and JAPAN.

Frequently asked questions

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

The registry currently lists 14 devices for Imris, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Imris, Inc.'s devices?

Among its 14 most recently registered devices, Imris, Inc. has devices listed in FDA 510(k) (14 devices).

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

Among its 14 most recently registered devices, the classes recorded for Imris, Inc.'s devices are Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Imris, Inc.?

FDA recall records list 1 recall initiated by Imris, Inc., the most recent initiated on 2014-10-01. 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 Imris, Inc. in the registry?

The most recently registered devices listed for Imris, Inc. include SYMBIS Surgical System, HFD100 ROCKER ARM ACCESSORY, NEURO II-SE, MODELS OR-MB-DR AND OR-DR and ICT.

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