# K261019: Anterion

- Pathway: 510(k) (Traditional)
- Applicant: Heidelberg Engineering GmbH
- Decided: Sep 11, 2026 after 168 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: 4 generations back to K051789 (2005). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K240924: Anterion, Heidelberg Engineering GmbH (2024) Summary page 5.

## Indications for use
The ANTERION is a non-contact ophthalmic imaging and analysis device for the eye. It is intended for visualization and measurement of the anterior segment and the measurement of the axial length. The analysis covers: • Cornea Thickness • Anterior Segment o Anterior chamber width, depth, volume and angle parameters o Lens Thickness • Axial Length

Source page: https://510kreport.com/device/K261019
Methodology: https://510kreport.com/methodology