# K060626: VUMAX

- Pathway: 510(k) (Special)
- Applicant: Sonomed, Inc.
- Decided: Apr 11, 2006 after 33 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
No predicates in its family tree.
7 later devices descend from it; 3 cite 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)
- None. The FDA summary names its predicate without a number.
- (no number) Sonomed EZ-Scan AB 5500+: named in the summary without a submission number

## Most influential descendants
- K140199: VUPAD (2014), 4 descendants of its own
- 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 VuMax ultrasound system is a multi-purpose computer-based ultrasonic diagnostic system for ophthalmic applications, intended to both visualize the interior of the eye by means of ultrasound and to make measurements inside the eye. The VuMax 35 MHz transducer is for use with the VuMax ultrasound. The VuMax 50 MHz transducer is for use with the Vumax ultrasound system.

Source page: https://510kreport.com/device/K060626
Methodology: https://510kreport.com/methodology