# K152250: SpeqRT

- Pathway: 510(k) (Traditional)
- Applicant: Signostics Limited
- Decided: Sep 3, 2015 after 24 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: 10 generations back to K935595 (1995). 68 ancestors in all.
No later device cites it as a predicate yet.
0 of 69 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130659: Speqrt Ultrasound System, Signostics Pty, Ltd. (2013) Summary page 8.
- K090505: Speq Ultrasound System, Signostics Pty, Ltd. (2009) Summary page 8.

## 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/K152250
Methodology: https://510kreport.com/methodology