# K140254: EZONO 4000

- Pathway: 510(k) (Traditional)
- Applicant: Ezono AG
- Decided: Feb 26, 2014 after 26 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
Longest line of descent: 8 generations back to K911783 (1994). 90 ancestors in all.
13 later devices descend from it; 2 cite it directly.
6 of 104 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120234: EZONO 3000, Life-Tech, Inc. (2012) Summary page 1.
- K112953: Terason T3000 Ultrasound Systems with Updated Needle Guidance Graphics, Teratech Corp. (2012) Summary page 1.
- K111818: Sonixgps Needle Sensor, Ultrasonix Medical Corporation (2012) Summary page 1.

## Cited in the summary but kept off the family tree
- K1130173: SonoSite M-Turbo. Number could not be read Summary page 1.

## Most influential descendants
- 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
- K220269: HM70 EVO Diagnostic Ultrasound System (2022), 3 descendants of its own

## Indications for use
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Indications For Use: The indications for use of the eZonotm 4000. as defined by FDA guidance documents, are: Fetal, Abdominal, Pediatric. Small Organ (breast, thyroid, testicle). Musculo-skeletal (Conventional). Musculo-skeletal (Superficial), Invasive diagnostic or therapeutic procedures. Retroperitoneum. Female reproductive system and fetus. Superficial structures & pathologies. Peripheral Vessel. Magnetic Needle guidance

Source page: https://510kreport.com/device/K140254
Methodology: https://510kreport.com/methodology