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16 Bit, Inc.

US

Last updated May 31, 2026

What 16 Bit, Inc. makes

16 Bit, Inc. develops X-ray image interpretive software designed to assist in the analysis and evaluation of radiographic images, including automated detection and measurement tools for clinical assessment.

The company’s products are classified as Class II medical devices under FDA regulations and are listed in the FDA’s 510(k) and Unique Device Identifier (UDI) databases. The manufacturer is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country
US
Address
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Website
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LinkedIn
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Facebook
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Email
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Phone
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PRRC Contact
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EUDAMED SRN
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FDA FEI Number
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DUNS Number
203879963

Catalogue (2)

DeviceModel / ReferenceRegistriesClassStatus
Rho Rho
FDA UDI
Class IIActive
Rho DEN230023
FDA 510(k)
Class IIActive

Related Companies

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Authorities

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FDA Establishments (1)

Establishments registered with the FDA under this company group, matched by name.

  • 16 Bit Inc Toronto Ontario · CA FEI 3033583855