# K130659: Speqrt Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Signostics Pty, Ltd.
- Decided: Apr 3, 2013 after 22 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: 9 generations back to K935595 (1995). 67 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 72 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.
- K090505: Speq Ultrasound System, Signostics Pty, Ltd. (2009) Summary page 1.

## Most influential descendants
- K160420: SpeqT (2016), 1 descendant of its own
- K181574: Uscan (2018), 0 descendants of its own
- K152250: SpeqRT (2015), 0 descendants of its own
- K143493: SignosRT Bladder Ultrasound System (2015), 0 descendants of its own

## Indications for use
The SpeqRT 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.

Source page: https://510kreport.com/device/K130659
Methodology: https://510kreport.com/methodology