# K120234: EZONO 3000

- Pathway: 510(k) (Traditional)
- Applicant: Life-Tech, Inc.
- Decided: Apr 19, 2012 after 85 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
14 later devices descend from it; 1 cites it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K140254: EZONO 4000 (2014), 13 descendants of its own
- K182894: HM70A Diagnostic Ultrasound System (2019), 10 descendants of its own
- K191055: HS40 Diagnostic Ultrasound System (2019), 9 descendants of its own
- K200339: HS40 Diagnostic Ultrasound System (2020), 8 descendants of its own
- K210713: HM70 EVO Diagnostic Ultrasound System (2021), 4 descendants of its own

## Indications for use
The intended use of the eZono 3000, as defined by FDA guidance documents, are: Ophthalmic Fetal (as enumerated in the IFU Tables) Abdominal Pediatric Small Organ (breast, thyroid, testicle) Invasive diagnostic or therapeutic procedures Peripheral vessel Musculo-skeletal (Conventional) Musculo-skeletal (Superficial) Retroperitoneum Female reproductive system and foetus Cardiac (Adult) Cardiac (Pediatric)

Source page: https://510kreport.com/device/K120234
Methodology: https://510kreport.com/methodology