# K143493: SignosRT Bladder Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Signostics, Ltd.
- Decided: Jan 14, 2015 after 36 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: 10 generations back to K935595 (1995). 69 ancestors in all.
No later device cites it as a predicate yet.
0 of 70 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033906: Portascan Bladder Scanner, Model PA00146, Mediwatch Plc (2003) Summary page 6.
- K130659: Speqrt Ultrasound System, Signostics Pty, Ltd. (2013) Summary page 6.

## Indications for use
SignosRT Bladder scanner projects ultrasound energy through the lower abdomen of a patient to obtain an image of the bladder that is used to non-invasively determine bladder volume. Users must have ultrasound training before using the device. Contraindications The SignosRT Bladder Scanner is designed for percutaneous scanning only. Do not attempt intracavity imaging; in particular, trans-esophageal, trans-vaginal and trans-rectal scans are contraindicated. The SignosRT Bladder Scanner is contraindicated for pregnant patients.

Source page: https://510kreport.com/device/K143493
Methodology: https://510kreport.com/methodology