# K060421: Sonara; Sonara/Tek

- Pathway: 510(k) (Traditional)
- Applicant: Viasys Healthcare, Inc.
- Decided: Nov 3, 2006 after 259 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K993939 (2000). 7 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051085: Doppler-Box, Compumedics Germany Gmgh (2005)
- K002533: TCD 100M, PWD13 Transducer, Spencer Technologies (2000) Summary page 1.
- K053648: Pioneer TC8080, Companion Iii, Viasys Neuro Care (2006) Summary page 1.

## Most influential descendants
- K170859: Dolphin/IQ and Dolphin/4D (2017), 2 descendants of its own
- K191023: Dolphin/IQ, Dolphin/4D and Dolphin/MAX (2019), 1 descendant of its own
- K202742: Dolphin/IQ, Dolphin/4D and Dolphin/MAX with Dolphin/XF robot accessory (2021), 0 descendants of its own

## Recalls of this device
- Jan 6, 2009 · Not classified · Z-0998-2009: Internal testing has identified several several scenarios where unexpected System lockups, shutdowns or system errors would render the Sonara unavailable for use until the Sonara can be restarted. The
- Jan 6, 2009 · Not classified · Z-0999-2009: Internal testing has identified several several scenarios where unexpected System lockups, shutdowns or system errors would render the Sonara unavailable for use until the Sonara can be restarted. The

## Indications for use
The Sonara and Sonara/tek Transcranial Doppler are medical ultrasound devices for measuring the blood flow velocities in arteries and in veins noninvasively, consistent with the FDA Ultrasound System and Transducer Indication for Use forms cleared with the 510(k).

Source page: https://510kreport.com/device/K060421
Methodology: https://510kreport.com/methodology