# K090505: Speq Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Signostics Pty, Ltd.
- Decided: May 7, 2009 after 70 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: 8 generations back to K935595 (1995). 66 ancestors in all.
107 later devices descend from it; 4 cite it directly.
2 of 174 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020112: 50S Tringa Ultrasound Imaging System, Pie Medical (2002) Summary page 1.
- K063761: Acuson P10 Diagnostic Ultrasound System, Siemens Medical Solutions USA, Inc. (2007) Summary page 1.
- K021628: Sonosite Hand-Caried Untrasound System (Powerseries), Sonosite,Inc. (2002) Summary page 1.

## Most influential descendants
- K102153: Mobius Ultrasound Imaging System (2011), 103 descendants of its own
- K133833: Nuvis Diagnostic Ultrasound System (2014), 87 descendants of its own
- K152899: Philips Lumify Diagnostic Ultrasound System (2015), 79 descendants of its own
- K162549: Lumify Ultrasound System (2016), 43 descendants of its own
- K151339: SONON Ultrasound Imaging System (Model: SONON 300C) (2015), 33 descendants of its own

## Indications for use
The Speq ultrasound system is for non-invasive imaging of the human body and is intended for the following applications: Fetal, Abdominal, Pediatric, Musculo-skeletal, Cardiac and Peripheral Vessel. Users must have ultrasound training before using the device. See the attached Indications for Use form for specific imaging modes and applications. The following warnings apply: Warning: Use in B-mode is not indicated where body structures are in rapid motion. Warning: Use in B-mode is not indicated where the application of pressure on the transducer will displace the tissue of interest. Warning: Use in B-mode is not indicated for catheter or needle placement where the real-time visualization of the structure of interest and needle is required.

Source page: https://510kreport.com/device/K090505
Methodology: https://510kreport.com/methodology