# K053325: Mediwatch Multiscan Ultrasound System/Scanner, Model M0002 (Scanner Only); Multiscan Ultrasound System, Model M0001

- Pathway: 510(k) (Abbreviated)
- Applicant: Mediwatch, Ltd.
- Decided: Dec 7, 2005 after 6 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
No predicates in its family tree.
17 later devices descend from it; 1 cites it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K091518: Cubescan Biocon-500 Diagnostic Ultrasound System (2009), 16 descendants of its own
- K111021: Cubescan / Biocon-700 (2011), 13 descendants of its own
- K131227: Padscan HD Series Bladder Scanner (2013), 7 descendants of its own
- K171591: CUBEScan™ BioCon-900 (Bladder Volume Measurement System) (2017), 4 descendants of its own
- K190769: Bladder Scanner (Models: M2, M2-W, M1, M1-W) (2019), 3 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: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Source page: https://510kreport.com/device/K053325
Methodology: https://510kreport.com/methodology