# K082326: Zonare Ultra Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Zonare Medical Systems, Inc.
- Decided: Oct 8, 2008 after 55 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: 11 generations back to K935595 (1995). 68 ancestors in all.
133 later devices descend from it; 2 cite it directly.
0 of 202 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022858: Supernova Diagnostic Ultrasound Scanning System, Novasonics, Inc. (2002) Summary page 1.
- K053435: GE Voluson I, General Electric Co. (2005) Summary page 1.
- K072786: Acuson S2000 Ultrasound System, Siemens Medical Solutions USA, Inc. (2007) Summary page 1.
- K042540: Philips IU22 Ultrasound System, Philips Ultrasound, Inc. (2004) Summary page 1.

## Most influential descendants
- K101091: Z.One Ultra Ultrasound System (2010), 132 descendants of its own
- K121699: Acuson X300 Diagnostic Ultrasound System Sonovista X300 Diagnostic Ultrasound System (2012), 98 descendants of its own
- K123622: Acuson (2012), 96 descendants of its own
- K123001: Acuson X700 Diagnstic Ultrasound System (2012), 74 descendants of its own
- K132804: Acuson S1000 / S2000 / S3000 (2013), 73 descendants of its own

## Indications for use
This device is intended for use by a qualified physician for ultrasound evaluation of the following: Fetal, Abdominal, Intraoperative, Pediatric, Small organ/parts (breast/testes, thyroid, etc), Transvaginal, Transrectal, Transcranial,Trans-esoph, Trans-urethral, OB/GYM, Cardiac, Pelvic, Neonatal/Adult cephalic. Vascular, 3D/4D, Tissue elasticity, Musculoskeletal (cardiac, Superficial Musculoskeletal, and Paipheral Vascular applications.

Source page: https://510kreport.com/device/K082326
Methodology: https://510kreport.com/methodology