Data / Medical devices / Canada / Optina Diagnostics Inc.
Optina Diagnostics Inc.: FDA-registered device maker in Montreal Quebec, Canada, 3 510(k) clearances
Optina Diagnostics Inc. is registered with the FDA (registration 3014606890) in Montreal Quebec, Canada. It lists 3 device types. The FDA files 3 510(k) clearances under its listings, the newest dated September 4, 2025. Registered through 2026. 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
- 3014606890
- Address
- 8200 Decarie Blvd, Suite #220, Montreal Quebec, Canada, H4P 2P5
- Owner or operator
- Optina Diagnostics (10081796)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- June 3, 2021
- Registered through
- 2026
- Brand names listed
- Mydriatic Hyperspectral Retinal Camera (MHRC-C1), Optina Fotys, Optina-4C
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Camera, Ophthalmic, Ac-Powered | HKI | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Device, Communications, Images, Ophthalmic | NFG | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| System, Image Management, Ophthalmic | NFJ | 2 | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| September 4, 2025 | K250770 | Optina-4C (MHRC-C1N) | HKI | Substantially Equivalent | Optina Diagnostics, Inc. | accessdata.fda.gov |
| December 5, 2023 | K231230 | Optina-4C (MHRC-C1N) | HKI | Substantially Equivalent | Optina Diagnostics, Inc. | accessdata.fda.gov |
| April 27, 2020 | K200254 | Mydriatic Hyperspectral Retinal Camera (MHRC-C1) | HKI | Substantially Equivalent | Optina Diagnostics | accessdata.fda.gov |
Compare with other makers
- All makers of Camera, Ophthalmic, Ac-Powered
- All makers of Device, Communications, Images, Ophthalmic
- All makers of System, Image Management, Ophthalmic
Updated September 4, 2025. 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.