# K063803: Acuson Antares Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc., Ultrasound DI
- Decided: Jan 5, 2007 after 14 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: 9 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K935595 (1995). 54 ancestors in all.
801 later devices descend from it; 3 cite it directly.
2 of 856 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063138: Modification to Acuson Antares Ultrasound System, Siemens Medical Solutions USA, Inc. (2006) Summary page 1.
- K050034: Sonoline Antares Diagnostic Ultrasound System, Siemens Medical Solutions USA, Inc. (2005) Summary page 6.
- K033196: Sonoline Antares with Clarify VE, Siemens Medical Solutions USA, Inc. (2003) Summary page 6.

## Most influential descendants
- 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
- K091970: Aixplorer Ultrasound System (2009), 528 descendants of its own

## Recalls of this device
- Aug 17, 2010 · Not classified · Z-1836-2011: There is an error in the estimation of mean pressure gradient in the Cardiac measurement package. The currently implemented calculation will result in an underestimation of the mean pressure gradient 
- Mar 1, 2010 · Not classified · Z-1853-2011: Image captured from the device may be erroneous.
- Oct 2, 2009 · Not classified · Z-1007-2011: ECG waveform does not accurately align with 2D, M-Mode or Spectral Images.
- Oct 2, 2009 · Not classified · Z-1005-2011: ECG waveform does not accurately align with 2D, M-Mode or Spectral Images.
- Oct 2, 2009 · Not classified · Z-1006-2011: ECG waveform does not accurately align with 2D, M-Mode or Spectral Images.
- Mar 21, 2008 · Not classified · Z-1766-2008: Software issue may result in distorted images and inaccurate measurements, which could lead to a misdiagnosis.
- Mar 21, 2008 · Not classified · Z-1767-2008: Software issue may result in distorted images and inaccurate measurements, which could lead to a misdiagnosis.
- Jul 10, 2007 · Not classified · Z-0298-2008: Image error: A software problem results in on-screen indications (graphics) that lead the user to believe that the patient's right and left and the transducer orientation are oriented the same. This i
- Jul 10, 2007 · Not classified · Z-0297-2008: Image errors: A software problem results in on-screen indications (graphics) that lead the user to believe that the patient's right and left and the transducer orientation are oriented the same. This 

## Indications for use
Ultrasound imaging or fluid flow analysis of the human body as follows:

Source page: https://510kreport.com/device/K063803
Methodology: https://510kreport.com/methodology