# K063138: Modification to Acuson Antares Ultrasound System

- Pathway: 510(k) (Special)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Nov 22, 2006 after 37 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: 8 generations back to K935595 (1995). 52 ancestors in all.
802 later devices descend from it; 1 cites it directly.
2 of 855 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052894: Sonoline G60 S Ultrasound System, Siemens Medical Solutions USA, Inc. (2005) Summary page 1.
- K033196: Sonoline Antares with Clarify VE, Siemens Medical Solutions USA, Inc. (2003) Summary page 1.
- K023720: Sonoline Antares Ultrasound System, Siemens Medical Solutions USA, Inc. (2002). Our reading of the summary gave K023729, FDA’s number for Siascope II (Astron Clinica Limited). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Antares Diagnostic Ultrasound System”.
- K052021: V5MS Transducer and MPT7-4 Multiplane Transesophageal Transducer, Siemens Medical Solutions USA, Inc. (2005) Summary page 1.
- K011252: Eub-6000 Diagnostic Ultrasound Scanner SP-711 Sonoprobe System, Hitachi Medical Corp. (2001) Summary page 3.

## Most influential descendants
- K063803: Acuson Antares Diagnostic Ultrasound System (2007), 801 descendants of its own
- K072786: Acuson S2000 Ultrasound System (2007), 800 descendants of its own
- K093563: IU22 Ultrasound System and Transducers (2010), 588 descendants of its own
- K083095: Sonixtouch Ultrasound System (2008), 582 descendants of its own
- K092271: GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4 (2009), 569 descendants of its own

## Indications for use
The Acuson Antares ultrasound imaging system is intended for the following applications: Abdominal, Intraoperative, Small Parts, Transcranial, OB/GYN, Cardiac, Intracardiac, Transesophageal, Pelvic, Neonatal/Adult Cephalic, Vascular, Intravascular, Musculoskeletal, Superficial Musculoskeletal, Great Vessel, 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/K063138
Methodology: https://510kreport.com/methodology