Optina Diagnostics, Inc.
CanadaFDA applicant, unverified FDA
- Devices
- 3
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA establishment
What Optina Diagnostics, Inc. makes
Optina Diagnostics, Inc. manufactures the Optina-4C device, which is classified as a Class II medical device.
The company is based in the US and its devices are listed in the FDA 510(k) registry.
Catalogue
Optina-4C (MHRC-C1N) Ref K231230
Regimes: 510(k) Registry: 510(k)Mydriatic Hyperspectral Retinal Camera (MHRC-C1) Ref K200254
Regimes: 510(k) Registry: 510(k)Optina-4C (MHRC-C1N) Ref K250770
Regimes: 510(k) Registry: 510(k)
FDA establishments
- Optina Diagnostics Inc. Montreal Quebec · CA FEI 3014606890
Frequently asked questions
How many devices does Optina Diagnostics, Inc. have in the registry?
The registry currently lists 3 devices for Optina Diagnostics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Optina Diagnostics, Inc.'s devices?
Among its 3 most recently registered devices, Optina Diagnostics, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Optina Diagnostics, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Optina Diagnostics, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Optina Diagnostics, Inc. in the registry?
The most recently registered devices listed for Optina Diagnostics, Inc. include Optina-4C (MHRC-C1N) and Mydriatic Hyperspectral Retinal Camera (MHRC-C1).
Which FDA establishments are linked to Optina Diagnostics, Inc.?
1 FDA establishment is linked to Optina Diagnostics, Inc. in the registry; they are listed on the company page.