# K183414: Absolu

- Pathway: 510(k) (Traditional)
- Applicant: Quantel Medical
- Decided: Mar 20, 2019 after 100 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). 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)
- K051851: Aviso Ophthalmic Ultrasound System, Quantel Medical (2005) Summary page 10.

## Indications for use
The Quantel Medical ABSOLU is intended to be used for: -Axial Length measurement of the eye by ultrasonic means; -Implanted IOL power calculation, using the Axial Length measurement; -Visualization of the interior of the eye and the orbit by A and B scans.

Source page: https://510kreport.com/device/K183414
Methodology: https://510kreport.com/methodology