# K163138: Clarius Ultrasound System

- Pathway: 510(k) (Abbreviated)
- Applicant: Clarius Mobile Health Corp.
- Decided: Nov 30, 2016 after 21 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 18 generations back to K935595 (1995). 211 ancestors in all.
28 later devices descend from it; 3 cite it directly.
6 of 240 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151339: SONON Ultrasound Imaging System (Model: SONON 300C), Healcerion Co., Ltd. (2015) Summary page 7.
- K152899: Philips Lumify Diagnostic Ultrasound System, Philips Healthcare, Inc. (2015) Summary page 7.
- K153626: SonoSite Edge II Ultrasound System, FUJIFILM Sonosite, Inc. (2016) Summary page 7.

## Most influential descendants
- K172385: Clarius Ultrasound System (2017), 22 descendants of its own
- K180799: Clarius Ultrasound Scanner (2018), 11 descendants of its own
- K192107: Clarius Ultrasound Scanner (2019), 10 descendants of its own
- K191235: Leltek Ultrasound Imaging System (2020), 9 descendants of its own
- K210432: LELTEK Ultrasound Imaging System (Model: LU700 Series) (2021), 8 descendants of its own

## Indications for use
Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows: Additional Comments: Includes imaging to assist in the placement of needles and catheters in vascular or other anatomical structures and imaging guidance for nerve block procedures. Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows: Additional Comments: Includes imaging to assist in the placement of needles and catheters in vascular or other anatomical structures and imaging guidance for nerve block procedures. Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows: Additional Comments: Includes imaging to assist in the placement of needles and catheters in vascular or other anatomical structures and imaging guidance for nerve block procedures.

Source page: https://510kreport.com/device/K163138
Methodology: https://510kreport.com/methodology