1 device · 1 company · 2015
Product code NFJ: System, Image Management, Ophthalmic
1 device under product code NFJ, 2015, from 1 company. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (1 of 1 here), the regulation, and MAUDE report counts by product code.
System, Image Management, Ophthalmic. 21 CFR 892.2050, Class II. MAUDE held 48 adverse-event reports against this product code as of 2026-10-29; reports are unverified and the code is shared by every device of this type.
Retrieved from FDA public records.
Every device, newest decision first
| Decision | Device | Company | Panel | FDA |
|---|---|---|---|---|
| IRIS INTELLIGENT RETINAL IMAGING SYSTEMK141922 · 510(k) | INTELLIGENT RETINAL IMAGING SYSTEMS, LLC | Radiology | database entry |
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