# K060410: Echoheart Transvaginal Doppler Probe

- Pathway: 510(k) (Traditional)
- Applicant: Summit Doppler Systems, Inc.
- Decided: Apr 10, 2006 after 53 days
- Product code: HEK (Monitor, Heart Sound, Fetal, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 884.2660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K930200 (1994). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K024197: Lifedop Doppler, Summit Doppler Systems, Inc. (2003) Summary page 1.
- K961073: Atlas 2.0 & Hitachi 2.0 (a Trade Name Subject to Change), Atlantis Diagnostics Intl., Inc. (1997) Summary page 1.

## 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:

Source page: https://510kreport.com/device/K060410
Methodology: https://510kreport.com/methodology