# K171301: Scanmate Flex

- Pathway: 510(k) (Traditional)
- Applicant: Dgh Technology, Inc.
- Decided: Jul 31, 2017 after 89 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 K843696 (1985). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140199: VUPAD, Sonomed, Inc. (2014) Summary page 9.
- K093371: Model DGH 6000 Scanmate a, Dgh Technology, Inc. (2010) Summary page 5.

## Indications for use
The Scanmate Flex is a multi-purpose computer-based ultrasonic diagnostic system for ophthalmic application, intended to both visualize the interior of the eye by means of ultrasound and to make measurements inside the eye, including the measurement of axial length for determination of IOL Power. The Scanmate Flex is intended for the examination of adult patients.

Source page: https://510kreport.com/device/K171301
Methodology: https://510kreport.com/methodology