# K171370: IMAGEnet 6 Ophthalmic Data System

- Pathway: 510(k) (Traditional)
- Applicant: Topcon Corporation
- Decided: Nov 1, 2017 after 175 days
- Product code: NFJ (System, Image Management, Ophthalmic)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K012727 (2002). 23 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132438: Imagenet 5 PC Software System, Topcon Medical Systems, Inc. (2013) Summary page 4.
- K161509: 3D OCT-1 Maestro, Topcon Corporation (2016) Summary page 4.

## Most influential descendants
- K232828: IMAGEnet6 Ophthalmic Data System (2024), 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

## Recalls of this device
- Mar 6, 2019 · Class II · Z-1138-2019: When a patient is selected in the patient data and another patient is selected prior to the display of the primary patient's thumbnails is completed, then the primary patient's thumbnails are displaye

## Indications for use
The IMAGEnet 6 Ophthalmic Data 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 devices without controlling or altering the functions and parameters of any medical devices or through computerized networks. It is intended for processing and displaying ophthalmic images and optical coherence tomography data. The IMAGEnet 6 Ophthalmic Data System uses the same algorithms and reference databases from the original data capture device as a quantitative tool for the comparison of posterior ocular measurements to a database of known normal subjects.

Source page: https://510kreport.com/device/K171370
Methodology: https://510kreport.com/methodology