# K160420: SpeqT

- Pathway: 510(k) (Traditional)
- Applicant: Signostics Limited
- Decided: Mar 21, 2016 after 34 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: 18 generations back to K935595 (1995). 178 ancestors in all.
1 later device descends from it; 1 cites it directly.
6 of 180 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 6.
- K090505: Speq Ultrasound System, Signostics Pty, Ltd. (2009) Summary page 6.
- K152899: Philips Lumify Diagnostic Ultrasound System, Philips Healthcare, Inc. (2015) Summary page 6.
- K071217: Bladderscan Bvi 9400 Ultrasound, Verathon Incorporated (2007) Summary page 6.

## Most influential descendants
- K181574: Uscan (2018), 0 descendants of its own

## Indications for use
The SpeqT is for non-invasive imaging of the human body and is intended for the following applications: Abdominal, Musculoskeletal, Pediatric, and Small Organ. Users must have ultrasound training for abdominal, musculoskeletal, pediatric, and small organ imaging. The SpeqT can also be used to obtain an image of the bladder that is used to automatically determine bladder volume. See the attached Indications for Use form for specific imaging modes and applications.

Source page: https://510kreport.com/device/K160420
Methodology: https://510kreport.com/methodology