# K051085: Doppler-Box

- Pathway: 510(k) (Traditional)
- Applicant: Compumedics Germany Gmgh
- Decided: May 5, 2005 after 7 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: 1 generation back to K931801 (1995). 2 ancestors in all.
5 later devices descend from it; 3 cite 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)
- K002533: TCD 100M, PWD13 Transducer, Spencer Technologies (2000) Summary page 1.
- K931801: Multi-Dop X, Dantec Medical, Inc. (1995) 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
- K141462: Varia-Nci (2014), 0 descendants of its own

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

Source page: https://510kreport.com/device/K051085
Methodology: https://510kreport.com/methodology