# Zonare Medical Systems, Inc.

- Location (FDA's records): Mountain View, CA
- FDA decisions: 6 (2008–2015): 6 510(k) clearances
- Product codes: IYN (6)
- Predicates its devices cite: 17 (8 its own); citations of its devices by later devices: 15 (8 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Novasonics, Inc.: 2 (https://510kreport.com/company/novasonics)
- Philips Ultrasound, Inc.: 2 (https://510kreport.com/company/philips-ultrasound)
- Ep Medsystems: 2 (https://510kreport.com/company/ep-medsystems)
- General Electric Co.: 1 (https://510kreport.com/company/general-electric)
- Siemens Medical Solutions USA, Inc.: 1 (https://510kreport.com/company/siemens-medical-solutions-usa)
- Sonosite,Inc.: 1 (https://510kreport.com/company/sonosite)

## Firms that cite its devices most
- Shenzhen Mindray Bio-Medical Electronics Co., Ltd.: 2 (https://510kreport.com/company/shenzhen-mindray-bio-medical-electronics)
- B-K Medical Aps: 2 (https://510kreport.com/company/b-k-medical)
- Toshiba America Medical Systems, In.C: 1 (https://510kreport.com/company/toshiba-america-medical-systems-in-c)
- Siemens Medical Solutions USA, Inc. Ultrasound Gro: 1 (https://510kreport.com/company/siemens-medical-solutions-usa-ultrasound-gro)
- Siemens Medical Solutions USA, Inc.: 1 (https://510kreport.com/company/siemens-medical-solutions-usa)

## Its most-cited devices
- K101091: Z.One Ultra Ultrasound System (2010), cited by 5
- K120703: Zonare ZS3 Diagnostic Unltrasound System (2012), cited by 4
- K151175: ZONARE ZS3 Diagnostic Ultrasound System (2015), cited by 2
- K082326: Zonare Ultra Ultrasound System (2008), cited by 2
- K141641: Zonare ZS3 Diagnostic Ultrasound System (2014), cited by 1
- K150249: ZONARE ZS3 and Z.Onepro Diagnostic Ultrasound System (2015), cited by 1

## Recent decisions
- K151175: ZONARE ZS3 Diagnostic Ultrasound System (May 15, 2015)
- K150249: ZONARE ZS3 and Z.Onepro Diagnostic Ultrasound System (Mar 4, 2015)
- K141641: Zonare ZS3 Diagnostic Ultrasound System (Jul 18, 2014)
- K120703: Zonare ZS3 Diagnostic Unltrasound System (Apr 13, 2012)
- K101091: Z.One Ultra Ultrasound System (Jun 25, 2010)
- K082326: Zonare Ultra Ultrasound System (Oct 8, 2008)

Source page: https://510kreport.com/company/zonare-medical-systems