# K023957: Sonosite Hand-Carried Ultrasound System (C2 Series)

- Pathway: 510(k) (Traditional)
- Applicant: Sonosite,Inc.
- Decided: Dec 12, 2002 after 15 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: 2 generations back to K961459 (1997). 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)
- K014116: Hand-Carried Ultrasound System, Sonosite,Inc. (2001). Our reading of the summary gave K044116, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “SonoSite hand-carried ultrasound system”. Summary page 10.
- K010374: Sonosite Hand-Carried Ultrasound System, Sonosite,Inc. (2001)
- K011224: Hdi 5000 Ultrasound System with Assisted Border Detection (Abd), Xres Imaging, and Panoramic Measurement Capability, Advanced Technology Laboratories, Inc. (2001)

## Indications for use
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Source page: https://510kreport.com/device/K023957
Methodology: https://510kreport.com/methodology