# K063388: Topcon 3D Oct-1000 Optical Coherence Tomography System

- Pathway: 510(k) (Traditional)
- Applicant: Topcon Corp.
- Decided: Jun 22, 2007 after 226 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
No predicates in its family tree.
41 later devices descend from it; 2 cite it directly.
0 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Carl Zeiss, Inc., Humphrey OCT Scanner: named in the summary without a submission number
- (no number) Carl Zeiss Ophthalmic Systems, Inc.'s, Humphrey OCT 3: named in the summary without a submission number

## Most influential descendants
- K072971: Topcon 3D Oct-1000 Optical Coherence Tomography System for Measurement of Retinal Thickness (2009), 39 descendants of its own
- K093313: Synergy (2009), 29 descendants of its own
- K122938: Forum Forum Archive Forum Archive & Viewer Forum Assist Match (2012), 25 descendants of its own
- K083316: 3D Oct-1000 Mark II Optical Coherence Tomography System (2009), 15 descendants of its own
- K092470: Optical Coherence Tomography 3D Oct-2000 (2009), 14 descendants of its own

## Indications for use
The Topcon 3D OCT-1000 is a non-contact ophthalmic imaging system for the viewing and axial cross sectional imaging of posterior ocular structures. It is used for in vivo imaging of the retina, retinal nerve fiber layer and optic disc. It is intended for use as a diagnostic device to aid in the detection and management of ocular diseases, including but not limited to macular edema and central serous retinopathy.

Source page: https://510kreport.com/device/K063388
Methodology: https://510kreport.com/methodology