# K973767: Harmonic Imaging with Contrast

- Pathway: 510(k) (Traditional)
- Applicant: Acuson Corp.
- Decided: Dec 23, 1997 after 82 days
- Product code: IYO (System, Imaging, Pulsed Echo, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K935595 (1995). 1 ancestor in all.
1,087 later devices descend from it; 8 cite it directly.
2 of 1,089 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K935595: Acuson Model 3001, Acuson Corp. (1995) Summary page 1.

## Most influential descendants
- K022567: Sequoia Signature II Diagnostic Ultrasound System (2002), 1,069 descendants of its own
- K032114: Sequoia 8.0 Diagnostic Ultrasound System (2003), 1,003 descendants of its own
- K041319: Sequoia Diagnostic Ultrasound System (2004), 988 descendants of its own
- K051139: Acuson Sequoia Diagnostic Ultrasound System (2005), 979 descendants of its own
- K052410: Acuson Sequoia Ultrasound System (2005), 972 descendants of its own

## Indications for use
The Sequoia™ Ultrasound System is intended for Harmonic Imaging and Conventional Contrast Imaging in conjunction with legally marketed contrast agents for the indications that they have been approved.” The TE-V5M transducer is intended for Harmonic Imaging and Conventional Contrast Imaging in conjunction with legally marketed contrast agents for the indications that they have been approved™. The 8LS transducer is intended for Harmonic Imaging and Conventional Contrast Imaging in conjunction with legally marketed contrast agents for the indications that they have been approved™. The 6L3 transducer is intended for Harmonic Imaging and Conventional Contrast Imaging in conjunction with legally marketed contrast agents for the indications that they have been approved™. The 15L8 transducer is intended for Harmonic Imaging and Conventional Contrast Imaging in conjunction with legally marketed contrast agents for the indications that they have been approved™. The 8V transducer is intended for Harmonic Imaging and Conventional Contrast Imaging in conjunction with legally marketed contrast agents for the indications that they have been approved™. The 7V3c transducer is intended for Harmonic Imaging and Conventional Contrast Imaging in conjunction with legally marketed contrast agents for the indications that they have been approved”. The 5V2c transducer is intended for Harmonic Imaging and Conventional Contrast Imaging in conjunction with legally marketed contrast agents for the indications that they have been approved”. The 3V2c transducer is intended for Harmonic Imaging and Conventional Contrast Imaging in conjunction with legally marketed contrast agents for the indications that they have been approved”. The 8C4 transducer is intended for Harmonic Imaging and Conventional Contrast Imaging in conjunction with legally marketed contrast agents for the indications that they have been approved”. The 5C2 transducer is intended for Harmonic Imaging and Conventional Contrast Imaging in conjunction with legally marketed contrast agents for the indications that they have been approved”. The 4V2 transducer is intended for Harmonic Imaging and Conventional Contrast Imaging in conjunction with legally marketed contrast agents for the indications that they have been approved™. The EV-8C4 transducer is intended for Harmonic Imaging and Conventional Contrast Imaging in conjunction with legally marketed contrast agents for the indications that they have been approved”. The Aux CW transducer is intended for Harmonic Imaging and Conventional Contrast Imaging in conjunction with legally marketed contrast agents for the indications that they have been approved”.

Source page: https://510kreport.com/device/K973767
Methodology: https://510kreport.com/methodology