# K083316: 3D Oct-1000 Mark II Optical Coherence Tomography System

- Pathway: 510(k) (Traditional)
- Applicant: Topcon Medical Systems, Inc.
- Decided: Mar 13, 2009 after 123 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.
15 later devices descend from it; 1 cites it directly.
0 of 17 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 1.

## Most influential descendants
- K092470: Optical Coherence Tomography 3D Oct-2000 (2009), 14 descendants of its own
- K112184: Cirrus Photo (2012), 13 descendants of its own
- K141844: Rescan 700, Callisto Eye (2014), 5 descendants of its own
- K150467: Retina Workplace (2015), 3 descendants of its own
- K133217: Cirrus Photo (2014), 3 descendants of its own

## Indications for use
The Topcon 3D OCT-1000 MARK II 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/K083316
Methodology: https://510kreport.com/methodology