# K120703: Zonare ZS3 Diagnostic Unltrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Zonare Medical Systems, Inc.
- Decided: Apr 13, 2012 after 36 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: 13 generations back to K935595 (1995). 82 ancestors in all.
24 later devices descend from it; 4 cite it directly.
0 of 107 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082326: Zonare Ultra Ultrasound System, Zonare Medical Systems, Inc. (2008) Summary page 1.
- K101091: Z.One Ultra Ultrasound System, Zonare Medical Systems, Inc. (2010) Summary page 1.

## Most influential descendants
- K141641: Zonare ZS3 Diagnostic Ultrasound System (2014), 21 descendants of its own
- K150249: ZONARE ZS3 and Z.Onepro Diagnostic Ultrasound System (2015), 20 descendants of its own
- K151175: ZONARE ZS3 Diagnostic Ultrasound System (2015), 19 descendants of its own
- K160381: TE7 Diagnostic Ultrasound System (2016), 13 descendants of its own
- K161525: TE7 Diagnostic Ultrasound, TE5 Diagnostic Ultrasound System (2016), 12 descendants of its own

## Indications for use
The device is intended for use by a qualified physician for ultrasound evaluation of Ophthalmic; Fetal/obstetric, gynecological; Abdominal (renal, GYN/Pelvic; Intra-operative (abdominal, thoracic, and vascular), Intra-operative neurological; Pediatric; Small organ (thyroid, breast, testes, etc), Adult & Neonatal Cephalic; Trans-rectal, Trans-vaginal, Trans-cranial, Trans-esophageal (non-cardiac and cardiac); Musculoskeletal (conventional & superficial); 3D/4D; Cardiac - Adult/Pediatric/Fetal;- Echo, Intra-Cardiac;, Pelvic; Peripheral vascular;, harmonic tissue and contrast imaging and Tissue elasticity.

Source page: https://510kreport.com/device/K120703
Methodology: https://510kreport.com/methodology