# K182942: Canon OCT-A1

- Pathway: 510(k) (Traditional)
- Applicant: Canon, Inc.
- Decided: Jul 24, 2019 after 274 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: 8 generations back to K012727 (2002). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153080: RTVue XR OCT Avanti with AngioVue Software, Optovue, Inc. (2016) Summary page 4.

## Indications for use
The Canon OCT-A1 is an optical coherence tomography system indicated for the in-vivo imaging and measurement of the retina, retinal nerve fiber layer, and optic disc as a tool and an aid in the diagnosis and management of retinal diseases by a clinician.

Source page: https://510kreport.com/device/K182942
Methodology: https://510kreport.com/methodology