Cleared Traditional

K141922 - IRIS INTELLIGENT RETINAL IMAGING SYSTEM (FDA 510(k) Clearance)

Class II Ophthalmic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K141922 · Intelligent Retinal Imaging Systems, LLC · Ophthalmic device
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Feb 2015
Decision
226d
Days
Class 2
Risk

K141922 is an FDA 510(k) clearance for the IRIS INTELLIGENT RETINAL IMAGING SYSTEM. Classified as System, Image Management, Ophthalmic (product code NFJ), Class II - Special Controls.

Submitted by Intelligent Retinal Imaging Systems, LLC (Andover, US). The FDA issued a Cleared decision on February 27, 2015 after a review of 226 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 892.2050 - the FDA ophthalmic device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Intelligent Retinal Imaging Systems, LLC devices

Submission Details

510(k) Number K141922 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 2014
Decision Date February 27, 2015
Days to Decision 226 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
116d slower than avg
Panel avg: 110d · This submission: 226d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NFJ System, Image Management, Ophthalmic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2050
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.

Regulatory Peers - NFJ System, Image Management, Ophthalmic

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