# K061153: Gynesonics EC6 Transducer

- Pathway: 510(k) (Traditional)
- Applicant: Gynesonics, Inc.
- Decided: Oct 27, 2006 after 184 days
- Product code: ITX (Transducer, Ultrasonic, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 892.1570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K926514 (1993). 12 ancestors in all.
7 later devices descend from it; 1 cites it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030191: Terason Model 2000/Bas Portable Ultrasound System, Teratech Corp. (2003) Summary page 6.
- K043278: Teratech Model 8IOC4, 8IOL4 & 10LAP4 Probes, Teratech Corp. (2004) Summary page 1.

## Most influential descendants
- K173703: Sonata Sonography-Guided Transcervical Fibroid Ablation System (2018), 6 descendants of its own
- K193516: Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1 (2020), 5 descendants of its own
- K211535: Sonata Transcervical Fibroid Ablation System 2.2 (2021), 4 descendants of its own
- K222304: Sonata Transcervical Fibroid Ablation System 2.2 (2022), 3 descendants of its own
- K233848: Sonata Transcervical Fibroid Ablation System 2.2 (SONATA2-220) (2023), 2 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:

Source page: https://510kreport.com/device/K061153
Methodology: https://510kreport.com/methodology