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Neotronics, Inc.

United StatesFDA applicant, unverified

Devices
2

What Neotronics, Inc. makes

Neotronics, Inc. manufactures the MOM 2, a medical imaging device designed for mammography, and the ERA 2000A, an automated radiography system for X-ray imaging. These products are intended for diagnostic imaging in clinical settings, including breast and general radiography applications.

The company’s portfolio includes Class II devices, which are regulated under the FDA’s 510(k) clearance process. These devices are listed in the FDA’s 510(k) database, reflecting their compliance with U.S. medical device regulations. The company is headquartered in the United States.

AI-generated from registry data, 1 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue2

Newest first, rows 1-2 of 2

  • Mom 2 Ref K801607

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Era 2000A Ref K911261

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

Frequently asked questions

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

The registry currently lists 2 devices for Neotronics, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Neotronics, Inc.'s devices?

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

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

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

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

The most recently registered devices listed for Neotronics, Inc. include MOM 2 and ERA 2000A.

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