# K071839: Soct Copernicus, Model 15205

- Pathway: 510(k) (Traditional)
- Applicant: Reichert, Inc.
- Decided: Feb 27, 2008 after 237 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: 2 generations back to K012727 (2002). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030433: Stratusoct with RNFL Normative Database, Carl Zeiss Meditec, Inc. (2003) Summary page 1.

## Indications for use
An optical coherence tomography system indicated for the in vivo imaging and measurement of the retina as an aid in the diagnosis and management of retinal diseases.

Source page: https://510kreport.com/device/K071839
Methodology: https://510kreport.com/methodology