# K994096: Sonoheart Hand-Carried Echocardiography System

- Pathway: 510(k) (Traditional)
- Applicant: Sonosite,Inc.
- Decided: Dec 20, 1999 after 17 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: 4 generations back to K894632 (1989). 21 ancestors in all.
196 later devices descend from it; 2 cite it directly.
3 of 218 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991710: Ssa-370A/Powervision 6000, Toshiba America Medical Systems, In.C (1999) Summary page 2.
- K991611: GE Logiq 500, General Electric Co. (1999) Summary page 2.
- K990806: C1 Ultrasound System, Sonosite,Inc. (1999) Summary page 2.
- K981505: Cozumel Diagnostic Ultrasound System, Sonosite,Inc. (1998) Summary page 8.

## Most influential descendants
- K063761: Acuson P10 Diagnostic Ultrasound System (2007), 135 descendants of its own
- K092756: GE Vscan Compact Diagnostic Ultrasound System (2009), 130 descendants of its own
- K090505: Speq Ultrasound System (2009), 107 descendants of its own
- K102153: Mobius Ultrasound Imaging System (2011), 103 descendants of its own
- K133833: Nuvis Diagnostic Ultrasound System (2014), 87 descendants of its own

## Indications for use
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Source page: https://510kreport.com/device/K994096
Methodology: https://510kreport.com/methodology