Data / Medical devices / United States / Intelligent Retinal Imaging Systems, Inc.
Intelligent Retinal Imaging Systems, Inc.: FDA-registered device maker in Pensacola, FL, United States, 1 510(k) clearance
Intelligent Retinal Imaging Systems, Inc. is registered with the FDA (registration 3011520729) in Pensacola, FL, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated February 27, 2015. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3011520729
- Address
- 2 North Palafox Suite 200, Pensacola, FL, United States, 32502
- Owner or operator
- Intelligent Retinal Imaging Systems, Inc. (10048903)
- Roles
- Manufacturer
- First device listed
- March 18, 2015
- Registered through
- 2026
- Brand names listed
- VELARA Integration Software
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 |
|---|---|---|---|---|---|---|
| February 27, 2015 | K141922 | IRIS INTELLIGENT RETINAL IMAGING SYSTEM | NFJ | Substantially Equivalent | Intelligent Retinal Imaging Systems, LLC | accessdata.fda.gov |
Compare with other makers
Updated February 27, 2015. 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.