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16 Bit, Inc.

Canada CA-MF-000048819 Last updated 22 Oct 2026

Devices
4
Registries
EUDAMEDGUDIDFDA 510(k)FDA
FDA recalls
0

Catalogue4

  • Rho Ref Rho

    Class II FDA UDI Active

  • Rho Ref 06287194090084

    Class IIa EUDAMED Active

  • Rho Ref Rho

    Class II FDA UDI

  • Rho Ref DEN230023

    Class II FDA 510(k) Active

FDA establishments1

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

  • 16 Bit Inc Toronto Ontario · CA FEI 3033583855

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
Canada
Address
20, Bay Street, Toronto, Canada
Website
www.16bit.ai/
PRRC contact
Catriona Syme
EUDAMED SRN
CA-MF-000048819
DUNS number
203879963