# K023720: Sonoline Antares Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Nov 20, 2002 after 15 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K001400 (2000). 2 ancestors in all.
896 later devices descend from it; 5 cite it directly.
2 of 899 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001400: Elegra Millennium Enhanced Diagnostic Ultrasound System, Siemens Medical Solutions USA, Inc. (2000) Summary page 1.
- K003525: Voluson 730 Diagnostic Ultrasound System, Medison America, Inc. (2000) Summary page 1.

## Most influential descendants
- K063138: Modification to Acuson Antares Ultrasound System (2006), 802 descendants of its own
- K063803: Acuson Antares Diagnostic Ultrasound System (2007), 801 descendants of its own
- K072786: Acuson S2000 Ultrasound System (2007), 800 descendants of its own
- K034003: Hdi 5000 Diagnostic Ultrasound System (2004), 677 descendants of its own
- K053069: Sonosite Micromaxx Diagnostic Ultrasound System (C3 Series) (2005), 676 descendants of its own

## Recalls of this device
- Mar 1, 2010 · Not classified · Z-1853-2011: Image captured from the device may be erroneous.

## Indications for use
The Antares ultrasound imaging system is intended for the following applications: General Radiology, Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Transesophageal, Pelvic, Neonatal/Adult Cephalic, Urology, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications. The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.

Source page: https://510kreport.com/device/K023720
Methodology: https://510kreport.com/methodology