Devices · INTELLIGENT RETINAL IMAGING SYSTEMS, LLC
IRIS INTELLIGENT RETINAL IMAGING SYSTEM
INTELLIGENT RETINAL IMAGING SYSTEMS, LLC is listed for IRIS INTELLIGENT RETINAL IMAGING SYSTEM (K141922). The FDA list gives February 27, 2015 as the date of the final decision. The lead panel is Radiology, and the database link on the FDA list is the 510(k) pathway. The primary product code on the FDA list is NFJ. openFDA did not return a classification record for that code in this copy of the data. openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K141922
- Date of final decision
- February 27, 2015
- Company on the FDA list
- INTELLIGENT RETINAL IMAGING SYSTEMS, LLC
- Lead panel
- Radiology
- Primary product code
- NFJ
- openFDA device name for the code
- System, Image Management, Ophthalmic
- Device class
- 2
- Regulation number
- 892.2050
- openFDA decision description
- Substantially Equivalent
- openFDA decision code
- SESE
- Statement or summary label
- Summary