# K132438: Imagenet 5 PC Software System

- Pathway: 510(k) (Traditional)
- Applicant: Topcon Medical Systems, Inc.
- Decided: Oct 17, 2013 after 73 days
- Product code: NFJ (System, Image Management, Ophthalmic)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
7 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K171370: IMAGEnet 6 Ophthalmic Data System (2017), 3 descendants of its own
- K232828: IMAGEnet6 Ophthalmic Data System (2024), 2 descendants of its own
- K173689: Ophthalmic Software Platform RX (2018), 2 descendants of its own
- K241081: 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2); IMAGEnet6 Ophthalmic Data System (2024), 1 descendant of its own
- K253893: Harmony Referral System with Harmony OCT Viewer (Octave) (2026), 0 descendants of its own

## Indications for use
The IMAGEnet 5 PC Software System is a software program that is intended for use in the collection, storage and management of digital images, patient data, diagnostic data and clinical information from Topcon imaging devices through a direct connection with Topcon instruments or through computerized networks.

Source page: https://510kreport.com/device/K132438
Methodology: https://510kreport.com/methodology