# K021628: Sonosite Hand-Caried Untrasound System (Powerseries)

- Pathway: 510(k) (Traditional)
- Applicant: Sonosite,Inc.
- Decided: May 31, 2002 after 14 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 K850478 (1985). 7 ancestors in all.
124 later devices descend from it; 5 cite it directly.
2 of 132 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) Summary page 2.
- K010374: Sonosite Hand-Carried Ultrasound System, Sonosite,Inc. (2001) Summary page 2.
- K961459: Level 10 Hdi, Advanced Technology Laboratories, Inc. (1997) Summary page 2.
- K993624: Site-Rite 3 Ultrasound System, Dymax Corp (1999) Summary page 2.

## Most influential descendants
- K090505: Speq Ultrasound System (2009), 107 descendants of its own
- K102153: Mobius Ultrasound Imaging System (2011), 103 descendants of its own
- 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

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

Source page: https://510kreport.com/device/K021628
Methodology: https://510kreport.com/methodology