# K102153: Mobius Ultrasound Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: Mobisante, Inc.
- Decided: Jan 20, 2011 after 174 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: 9 generations back to K935595 (1995). 81 ancestors in all.
103 later devices descend from it; 4 cite it directly.
2 of 185 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 1.
- K092756: GE Vscan Compact Diagnostic Ultrasound System, Ge Vingmed Ultrasound AS (2009) Summary page 1.
- K090505: Speq Ultrasound System, Signostics Pty, Ltd. (2009) Summary page 1.

## Most influential descendants
- K133833: Nuvis Diagnostic Ultrasound System (2014), 87 descendants of its own
- K152899: Philips Lumify Diagnostic Ultrasound System (2015), 79 descendants of its own
- K162549: Lumify Ultrasound System (2016), 43 descendants of its own
- K151339: SONON Ultrasound Imaging System (Model: SONON 300C) (2015), 33 descendants of its own
- K192226: Lumify Diagnostic Ultrasound System (2019), 31 descendants of its own

## Indications for use
The MobiUS Ultrasound Imaging System is indicated for ultrasound imaging, measurement and analysis of the human body for the following clinical applications: fetal/OB, abdominal, cardiac, pelvic, pediatric, musculoskeletal, and peripheral vessel imaging. Its compact size, portability and user interface enable it for use in primary care and special care areas. Diagnostic ultrasound imaging of the human body as follows: Diagnostic ultrasound imaging of the human body as follows: Diagnostic ultrasound imaging of the human body as follows: Diagnostic ultrasound imaging of the human body as follows: Diagnostic ultrasound imaging of the human body as follows: Diagnostic ultrasound Imaging of the human body as follows:

Source page: https://510kreport.com/device/K102153
Methodology: https://510kreport.com/methodology