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Confirma, Inc.

United StatesFDA applicant, unverified

Devices
9

What Confirma, Inc. makes

Confirma, Inc. manufactures medical devices including CADSTREAM software versions 3.1, 4.0, 5.0, and 5, which are used for computer-aided detection in medical imaging. The company also produces ACCESS BREAST COIL and ACCESS BREAST COIL 4/SMS, as well as CONFIRMA BREAST MRI INTERVENTIONAL COMPONENTS and ACCENT, which are related to breast MRI procedures.

Confirma, Inc. is based in the US and its devices are classified as Class II, listed in the FDA 510(k) registry. The company's portfolio includes software and hardware components specifically designed for breast MRI applications and interventional procedures.

AI-generated from registry data, 29 Sep 2026. Not verified by deviCERTS or the manufacturer.

Catalogue9

Newest first, rows 1-9 of 9

  • Cadstream Version 4.0 Ref K043216

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

  • Access Breast Coil 4/Sms Ref K060547

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

  • Accent Ref K013574

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

  • Confirma Breast Mri Interventional Components Ref K071534

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

  • Cadstream, Version 5.0 Ref K081556

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

  • Cadstream Ref K031779

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

  • Access Breast Coil Ref K052045

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

  • Cadstream Version 5 Ref K092954

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

  • Cadstream Version 3.1 Ref K041020

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

Frequently asked questions

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

The registry currently lists 9 devices for Confirma, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Confirma, Inc.'s devices?

Among its 9 most recently registered devices, Confirma, Inc. has devices listed in FDA 510(k) (9 devices).

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

Among its 9 most recently registered devices, the classes recorded for Confirma, Inc.'s devices are Class II. Each device page shows its own class and authorisation.

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

The most recently registered devices listed for Confirma, Inc. include CADSTREAM VERSION 4.0, ACCESS BREAST COIL 4/SMS, ACCENT and CONFIRMA BREAST MRI INTERVENTIONAL COMPONENTS.

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