# K152573: 4Sight

- Pathway: 510(k) (Traditional)
- Applicant: Accutome, Inc.
- Decided: Nov 25, 2015 after 77 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 K871536 (1987). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123349: A-Scan Plus Connect, Accutome, Inc. (2013) Summary page 5.
- K070943: B-Scan Plus, Accutome Ultrasound, Inc. (2007) Summary page 5.
- K042752: Accupach V, Accutome Ultrasound, Inc. (2004) Summary page 5.

## Indications for use
The 4Sight is a multi-purpose diagnostic ophthalmic ultrasound system intended to make axial length, anterior chamber depth, lens thickness and corneal thickness measurements of the eye and visualize the internal structure of the eye.

Source page: https://510kreport.com/device/K152573
Methodology: https://510kreport.com/methodology