Data / Medical devices / Canada / 16 Bit Inc
16 Bit Inc: FDA-registered device maker in Toronto Ontario, Canada, 1 510(k) clearance
16 Bit Inc is registered with the FDA (registration 3033583855) in Toronto Ontario, Canada. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated April 9, 2024. Registered through 2027. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3033583855
- Address
- 20 Bay Street, 11th Floor, Toronto Ontario, Canada, M5J 2N8
- Owner or operator
- 16 Bit Inc (10091425)
- Roles
- Manufacturer
- First device listed
- October 3, 2024
- Registered through
- 2027
- Brand names listed
- Rho
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Radiology Software For Opportunistic Evaluation Of Low Bone Mineral Density | SAO | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 9, 2024 | DEN230023 | Rho | SAO | Unknown | 16 Bit, Inc. | accessdata.fda.gov |
Updated April 9, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.