# K094038: Compact Touch

- Pathway: 510(k) (Traditional)
- Applicant: Quantel S.A.
- Decided: Apr 22, 2010 after 113 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: 3 generations back to K926251 (1993). 7 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051851: Aviso Ophthalmic Ultrasound System, Quantel Medical (2005) Summary page 2.
- K993674: Pocket Ultrasonic Pachymeter, Quantel Medical (2000) Summary page 2.

## Most influential descendants
- K180265: COMPACT TOUCH Ophthalmic Ultrasound System (2018), 1 descendant of its own
- K213254: Axialis Ophthalmic Ultrasound System (2021), 0 descendants of its own
- K102027: Axis Nano Opthalmic Biometer Ultrasound System (2010), 0 descendants of its own

## Indications for use
The QUANTEL MEDICAL 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/K094038
Methodology: https://510kreport.com/methodology