# K253893: Harmony Referral System with Harmony OCT Viewer (Octave)

- Pathway: 510(k) (Traditional)
- Applicant: Topcon Healthcare Solutions EMEA Oy
- Decided: Jun 4, 2026 after 182 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
Longest line of descent: 12 generations back to K896095 (1990). 61 ancestors in all.
No later device cites it as a predicate yet.
0 of 62 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210396: Harmony Referral System, Topcon Healthcare Solutions EMEA Oy (2021) Summary page 5.
- K241081: 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2); IMAGEnet6 Ophthalmic Data System, Topcon Corporation (2024) Summary page 5.

## Indications for use
Harmony Referral System (Harmony RS) is a comprehensive software platform intended for use in importing, processing, viewing, measurement and storage of clinical images and videos as well as in management and communication of patient data, diagnostic and clinical information and reports from ophthalmic diagnostic instruments through either direct connection with the instruments or through computerized networks. The system neither performs any interpretations nor provides treatment recommendations. The optional Harmony OCT Viewer module extends the indications with: Harmony OCT viewer is intended for processing, viewing, analyzing, and providing measurements of clinical optical coherence tomography (OCT) and fundus images from any OCT acquisition device, in conjunction with the Harmony RS as a medical image communication system. It is not intended to provide treatment recommendations. Harmony OCT viewer is indicated to be used as an aid in diagnosis and monitoring by quantitative assessment of anatomic structures in the eye for various diseases. For Topcon OCT devices, it uses reference databases from the original data capture device as a quantitative tool for the comparison to normal subjects. Harmony OCT Viewer does not, in itself, provide diagnoses or perform treatment or active monitoring.

Source page: https://510kreport.com/device/K253893
Methodology: https://510kreport.com/methodology