Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3033583855

FEI Number

3033583855

Entity Name

16 BIT INC

City/State/Country

Toronto Ontario, CA

Establishment Address

20 Bay Street, 11th Floor, Toronto Ontario M5J 2N8, CA

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

16 Bit Inc (Owner Number: 10091425)

Owner / Operator Contact Address

20 Bay Street, 11th Floor, Toronto, CA-ON M5J 2N8, CA

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

DEN230023

PMA Number

N/A

All Registered Proprietary Names

Rho

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
SAO	Radiology Software For Opportunistic Evaluation Of Low Bone Mineral Density	Radiology	Class 2	892.1171	2024-10-03

Official Correspondent

Catriona Syme

US Agent Details

Emily Matorin Business: FDAbasics Email: usagent@fdabasics.com Phone: (716) 7750533

Related Public Records

Same Entity

16 Bit Inc

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3033583855. Last updated year: 2026. Please use registration number 3033583855 when referencing this establishment in official correspondence.