# K140199: VUPAD

- Pathway: 510(k) (Traditional)
- Applicant: Sonomed, Inc.
- Decided: Apr 1, 2014 after 64 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: 2 generations back to K843696 (1985). 4 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040668: E-Z Scan AB5500+, Sonomed, Inc. (2004) Summary page 1.
- K060626: VUMAX, Sonomed, Inc. (2006) Summary page 1.

## Most influential descendants
- K170761: LIGHTSonic BUBM (2018), 1 descendant of its own
- K213070: MD-320W Ultrasound Biomicroscope (2021), 0 descendants of its own
- K183173: LIGHTMED Ultrasound System (2019), 0 descendants of its own
- K171301: Scanmate Flex (2017), 0 descendants of its own

## Indications for use
The VuPad ultrasound system 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 VuPad ultrasound system 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 VuPad ultrasound system 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 VuPad ultrasound system 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 VuPad ultrasound system 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.

Source page: https://510kreport.com/device/K140199
Methodology: https://510kreport.com/methodology