# K151175: ZONARE ZS3 Diagnostic Ultrasound System

- Pathway: 510(k) (Special)
- Applicant: Zonare Medical Systems, Inc.
- Decided: May 15, 2015 after 14 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: 16 generations back to K935595 (1995). 85 ancestors in all.
19 later devices descend from it; 2 cite it directly.
0 of 105 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150249: ZONARE ZS3 and Z.Onepro Diagnostic Ultrasound System, Zonare Medical Systems, Inc. (2015) Summary page 24.

## Most influential descendants
- 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
- K180912: TE7/TE5 Diagnostic Ultrasound System (2018), 11 descendants of its own
- K203391: TE7/TE5/TE7 Max/TE5 Max/TE9 Diagnostic Ultrasound System (2021), 7 descendants of its own
- K212265: TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite Diagnostic Ultrasound System, TEX10/ TEX10 Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite Diagnostic Ultrasound System (2021), 6 descendants of its own

## Indications for use
The ZS3 and z.one PRO Ultrasound Systems are 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); Musculosketal (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/K151175
Methodology: https://510kreport.com/methodology