# K170164: 3D OCT-1 Maestro

- Pathway: 510(k) (Special)
- Applicant: Topcon Corporation
- Decided: Mar 3, 2017 after 44 days
- Product code: OBO (Tomography, Optical Coherence)
- Device class: 2
- Regulation: 21 CFR 886.1570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K012727 (2002). 22 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161509: 3D OCT-1 Maestro, Topcon Corporation (2016) Summary page 4.

## Most influential descendants
- K231222: 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2) (2023), 3 descendants of its own
- K233561: 3D Optical Coherence Tomography (3D OCT-1(type: Maestro2)) (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
- K173119: DRI OCT Triton (2018), 0 descendants of its own

## Indications for use
The Topcon 3D OCT-1 Maestro is a non-contact, high resolution tomographic and biomicroscopic imaging device that incorporates a digital camera for photographing, displaying and storing the data of the retina and surrounding parts of the eye to be examined under Mydriatic and non-Mydriatic conditions. The 3D OCT-1 Maestro is indicated for in vivo viewing, axial cross sectional, and three-dimensional imaging and measurement of posterior ocular structures, including retina, retinal nerve fiber fayer, macula and optic disc as well as imaging of anterior ocular structures. It also includes a Reference Database for posterior ocular measurements which provide for the quantitative comparison of retinal nerve fiber layer, optic nerve head, and the macufa in the human retina to a database of known normal subjects. The 3D OCT-1 Maestro is indicated for use as a diagnostic device to aid in the diagnosis, documentation and management of ocular heaith and diseases in the adult population.

Source page: https://510kreport.com/device/K170164
Methodology: https://510kreport.com/methodology