# K160792: Morpheus RealTime Ultrasound, Pathway RealTime Ultrasound, QuickScan Bladder Ultrasound

- Pathway: 510(k) (Traditional)
- Applicant: The Prometheus Group
- Decided: Apr 15, 2016 after 23 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 K903603 (1991). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070907: Interson Usb Ultrasound Probe System, Regulatory Management Services (2007) Summary page 5.

## Indications for use
Morpheus® RealTime Ultrasound, Pathway® RealTime Ultrasound, QuickScan® Bladder Ultrasound are diagnostic ultrasound systems designed to be used for general pelvic imaging. An ultrasonographic crystal within the probe records images of the organ, muscle, and tissue structures of the pelvic region. Measurements and calculations of the organ, muscle, and tissue structures can be recorded.

Source page: https://510kreport.com/device/K160792
Methodology: https://510kreport.com/methodology