# K040213: MHLX7EC Transducer

- Pathway: 510(k) (Traditional)
- Applicant: Microhelix, Inc.
- Decided: Sep 22, 2004 after 236 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: 3 generations back to K934915 (1994). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013849: Tetrad Model TC-EC7-Acp, -L5-, -L7-, -V4-Acp Transducers, Tetrad Corp. (2001) Summary page 1.
- K991805: Aspen Ultrasound with Freestyle Imaging Option, Acuson Corp. (1999) 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/K040213
Methodology: https://510kreport.com/methodology