# K072971: Topcon 3D Oct-1000 Optical Coherence Tomography System for Measurement of Retinal Thickness

- Pathway: 510(k) (Traditional)
- Applicant: Topcon Medical Systems, Inc.
- Decided: Jan 13, 2009 after 449 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: 1 generation back to K063388 (2007). 1 ancestor in all.
39 later devices descend from it; 2 cite it directly.
0 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063388: Topcon 3D Oct-1000 Optical Coherence Tomography System, Topcon Corp. (2007) Summary page 2.
- (no number) STRATUSOCT with Retinal Nerve Fiber Layer and Macula Normative Database: named in the summary without a submission number
- (no number) RTA 5 & RTA Model E Retinal Thickness Analyzer: named in the summary without a submission number
- (no number) RTA Retinal Thickness Analyzer: named in the summary without a submission number

## Most influential descendants
- K093313: Synergy (2009), 29 descendants of its own
- K122938: Forum Forum Archive Forum Archive & Viewer Forum Assist Match (2012), 25 descendants of its own
- K092470: Optical Coherence Tomography 3D Oct-2000 (2009), 14 descendants of its own
- K112184: Cirrus Photo (2012), 13 descendants of its own
- K132667: Synergy Odm (2013), 9 descendants of its own

## Indications for use
The Topcon 3D OCT-1000 is a non-contact, high resolution tomographic and biomicroscopic imaging device. It is indicated for in vivo viewing, axial, cross-sectional and three-dimensional imaging and measurements of posterior ocular structures, including retina, retinal nerve fiber layer, macula, and optic disc. It is intended for use as a diagnostic device to aid in the detection and management of ocular diseases affecting the posterior segment of the eye.

Source page: https://510kreport.com/device/K072971
Methodology: https://510kreport.com/methodology