# K014116: Hand-Carried Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Sonosite,Inc.
- Decided: Dec 20, 2001 after 6 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: 1 generation back to K961459 (1997). 3 ancestors in all.
433 later devices descend from it; 6 cite it directly.
2 of 437 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010374: Sonosite Hand-Carried Ultrasound System, Sonosite,Inc. (2001) Summary page 2.
- K003399: Sonosite Hand-Carried Ultrasound System, Sonosite,Inc. (2000) Summary page 2.
- K961459: Level 10 Hdi, Advanced Technology Laboratories, Inc. (1997) Summary page 2.

## Most influential descendants
- K101757: Sonosite Nanomaxx Series Ultrasound System, Sonosite Maxx Series Ultrasound System (2010), 339 descendants of its own
- K021628: Sonosite Hand-Caried Untrasound System (Powerseries) (2002), 124 descendants of its own
- K113647: DC-8/DC-8 Pro/DC-8 CV/DC-8 Exp/DC-8S Diagnostic Ultrasound System (2011), 116 descendants of its own
- K121010: M7/M7T Diagnostic Ultrasound System (2012), 107 descendants of its own
- K090505: Speq Ultrasound System (2009), 107 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 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/K014116
Methodology: https://510kreport.com/methodology