# K003399: Sonosite Hand-Carried Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Sonosite,Inc.
- Decided: Nov 16, 2000 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
No predicates in its family tree.
434 later devices descend from it; 1 cites it directly.
2 of 435 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K014116: Hand-Carried Ultrasound System (2001), 433 descendants of its own
- 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

Source page: https://510kreport.com/device/K003399
Methodology: https://510kreport.com/methodology