# K180265: COMPACT TOUCH Ophthalmic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Quantel Medical
- Decided: Mar 2, 2018 after 30 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: 4 generations back to K926251 (1993). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K094038: Compact Touch, Quantel S.A. (2010) Summary page 8.

## Most influential descendants
- K213254: Axialis Ophthalmic Ultrasound System (2021), 0 descendants of its own

## Indications for use
The COMPACT TOUCH Ophthalmic Ultrasound System and the probes that are used with it are indicated for diagnostic imaging and biometric measurement of the eye including: • Visualization of the interior of the eye and the orbit by A and B scans. • 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/K180265
Methodology: https://510kreport.com/methodology