# K024114: A-SCAN 100

- Pathway: 510(k) (Special)
- Applicant: Ophthalmic Technologies, Inc.
- Decided: Jan 10, 2003 after 28 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: 1 generation back to K960622 (1996). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960622: I-SCAN, Ophthalmic Technologies, Inc. (1996) Summary page 2.

## Indications for use
The A-scan 100 is an ophthalmic A-scan system intended to be used for measurement of axial distances in the eye and for the calculation of the power of an implanted intraocular lens (IOL), indicated for patients requiring intraocular lenses,

Source page: https://510kreport.com/device/K024114
Methodology: https://510kreport.com/methodology