Cleared Traditional

K141922 - IRIS INTELLIGENT RETINAL IMAGING SYSTEM

K141922 is an FDA 510(k) clearance for IRIS INTELLIGENT RETINAL IMAGING SYSTEM, manufactured by Intelligent Retinal Imaging Systems, LLC. The device is a Class 2 Ophthalmic device with product code NFJ cleared through the Traditional 510(k) pathway after a 226-day FDA review.

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

FDA 510(k) Submission Details - K141922

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.

NFJ Device Classification - Class 2, Special Controls

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

All 35
Devices cleared under the same product code (NFJ) and FDA review panel - the closest regulatory comparables to K141922.
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