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Ote Biomedica

Country not established

Devices
2

What Ote Biomedica makes

Ote Biomedica manufactures medical imaging systems designed for breast cancer detection, including the Model 8000 Sector Imager System and the Model 8100 Sector Imager. These devices use tomosynthesis technology to provide detailed, three-dimensional images of breast tissue, aiding in early diagnosis and improved assessment of abnormalities.

The company’s imaging systems are classified under the FDA’s 510(k) pathway, reflecting their status as moderate-risk devices (Class II). They are registered with the U.S. Food and Drug Administration and are intended for use in clinical settings within the United States.

AI-generated from registry data, 20 Sep 2026. Not verified by deviCERTS or the manufacturer.

Catalogue2

Newest first, rows 1-2 of 2

  • Model 8000 Sector Imager System Ref K827286

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

  • Model 8100 Sector Imager Ref K827287

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

Frequently asked questions

How many devices does Ote Biomedica have in the registry?

The registry currently lists 2 devices for Ote Biomedica. Devices recorded under merged duplicate company entries are counted once.

Which registries list Ote Biomedica's devices?

Among its 2 most recently registered devices, Ote Biomedica has devices listed in FDA 510(k) (2 devices).

What are the newest devices from Ote Biomedica in the registry?

The most recently registered devices listed for Ote Biomedica include MODEL 8000 SECTOR IMAGER SYSTEM and MODEL 8100 SECTOR IMAGER.

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