# K123349: A-Scan Plus Connect

- Pathway: 510(k) (Special)
- Applicant: Accutome, Inc.
- Decided: Jan 29, 2013 after 90 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 K871536 (1987). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032956: Accusonic a-Scan  Model, 24-4000, Accutome, Inc. (2003) Summary page 1.

## Most influential descendants
- K152573: 4Sight (2015), 0 descendants of its own

## Indications for use
This instrument is used for measuring the axial length, anterior chamber depth and lens thickness of the eye. It also is used for calculating the optical power of the IOL to be implanted during cataract surgery.

Source page: https://510kreport.com/device/K123349
Methodology: https://510kreport.com/methodology