# K053648: Pioneer TC8080, Companion Iii

- Pathway: 510(k) (Abbreviated)
- Applicant: Viasys Neuro Care
- Decided: Jan 24, 2006 after 25 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 K993939 (2000). 3 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020754: Nicolet Pioneer TC8080, Nicolet Biomedical (2003) Summary page 1.
- K011224: Hdi 5000 Ultrasound System with Assisted Border Detection (Abd), Xres Imaging, and Panoramic Measurement Capability, Advanced Technology Laboratories, Inc. (2001)

## Cited in the summary but kept off the family tree
- K864695: ML TC2-64B. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1.

## Most influential descendants
- K060421: Sonara; Sonara/Tek (2006), 3 descendants of its own
- 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

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

Source page: https://510kreport.com/device/K053648
Methodology: https://510kreport.com/methodology