Cleared Traditional

K132438 - IMAGENET 5 PC SOFTWARE SYSTEM (FDA 510(k) Clearance)

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

K132438 · Topcon Medical Systems, Inc. · Ophthalmic device
Oct 2013
Decision
73d
Days
Class 2
Risk

K132438 is an FDA 510(k) clearance for the IMAGENET 5 PC SOFTWARE SYSTEM. Classified as System, Image Management, Ophthalmic (product code NFJ), Class II - Special Controls.

Submitted by Topcon Medical Systems, Inc. (North Reading, US). The FDA issued a Cleared decision on October 17, 2013 after a review of 73 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

Submission Details

510(k) Number K132438 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 2013
Decision Date October 17, 2013
Days to Decision 73 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Regulatory Context
Review time vs. panel average
83d faster than avg
Panel avg: 156d · This submission: 73d
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.