# K161509: 3D OCT-1 Maestro

- Pathway: 510(k) (Traditional)
- Applicant: Topcon Corporation
- Decided: Jul 28, 2016 after 57 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: 7 generations back to K012727 (2002). 21 ancestors in all.
8 later devices descend from it; 3 cite it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121739: Ivue with Normative Database, Optovue, Inc. (2013) Summary page 4.
- K123460: TRC-NW300 Non-Mydriatic Retinal Camera, Topcon Medical Systems, Inc. (2013) Summary page 4.

## Most influential descendants
- K170164: 3D OCT-1 Maestro (2017), 5 descendants of its own
- K231222: 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2) (2023), 3 descendants of its own
- K171370: IMAGEnet 6 Ophthalmic Data System (2017), 3 descendants of its own
- K233561: 3D Optical Coherence Tomography (3D OCT-1(type: Maestro2)) (2024), 2 descendants of its own
- K232828: IMAGEnet6 Ophthalmic Data System (2024), 2 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 layer, 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 macula 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 health and diseases in the adult population.

Source page: https://510kreport.com/device/K161509
Methodology: https://510kreport.com/methodology