# K040409: Larsen & Toubro Limited Senorita Color Doppler Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Larsen & Toubro Limited
- Decided: Feb 27, 2004 after 9 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 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)
- K946277: Tetrad 2300 E/U Ultrasoung Imaging System, Tetra Corp. (1996) 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: 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/K040409
Methodology: https://510kreport.com/methodology