# K213254: Axialis Ophthalmic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Quantel Medical
- Decided: Nov 15, 2021 after 46 days
- Product code: IYO (System, Imaging, Pulsed Echo, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K926251 (1993). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180265: COMPACT TOUCH Ophthalmic Ultrasound System, Quantel Medical (2018) Summary page 4.

## Indications for use
The AXIALIS Ophthalmic Ultrasound System and the probes that are used with it are indicated for diagnostic imaging and biometric measurement of the eye including: Axial Length measurement of the eye by ultrasonic means. Implanted IOL power calculation, using the Axial Length measurement. Measurement of corneal thickness by ultrasonic means.

Source page: https://510kreport.com/device/K213254
Methodology: https://510kreport.com/methodology