Data / Medical devices / Canada / Diagnos Inc.
Diagnos Inc.: FDA-registered device maker in Brossard Quebec, Canada, 1 510(k) clearance
Diagnos Inc. is registered with the FDA (registration 3009422347) in Brossard Quebec, Canada. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated July 14, 2011. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009422347
- Address
- 7005 Taschereau Blvd. Suite 265, Brossard Quebec, Canada, J4Z1A7
- Owner or operator
- Diagnos Inc. (10057825)
- Roles
- Manufacturer
- First device listed
- May 30, 2018
- Registered through
- 2026
- Brand names listed
- CARA
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Image Management, Ophthalmic | NFJ | 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 |
|---|---|---|---|---|---|---|
| July 14, 2011 | K110869 | CARA | NFJ | Substantially Equivalent | Diagnos, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| January 11, 2022 | 89715 | Class II | Terminated | CARA (Computer Assisted Retinal Analysis), Product ID: +B543CARA0/$$+7V4.7.2/16D202111179 | Retinal analysis system software has some features, based on artificial intelligence, that potentially lack appropriate market approval, so it is recommended to use a specific prior software version. | accessdata.fda.gov |
Compare with other makers
Updated July 14, 2011. 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.