# K033906: Portascan Bladder Scanner, Model PA00146

- Pathway: 510(k) (Traditional)
- Applicant: Mediwatch Plc
- Decided: Dec 24, 2003 after 7 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: 3 generations back to K944287 (1995). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 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 4.

## Most influential descendants
- K143493: SignosRT Bladder Ultrasound System (2015), 0 descendants of its own

## Indications for use
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Source page: https://510kreport.com/device/K033906
Methodology: https://510kreport.com/methodology