# K043139: Uscom 1A

- Pathway: 510(k) (Traditional)
- Applicant: Uscom, Ltd.
- Decided: Feb 15, 2005 after 95 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 K000695 (2000). 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)
- K020789: GE Vivid 3 Expert; GE Vivid 3 Pro, General Electric Co. (2002) Summary page 1.
- K011439: Modification to Bioz.Com Hemodynamic Monitor, Cardiodynamics International Corp. (2001) Summary page 2.

## 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:

Source page: https://510kreport.com/device/K043139
Methodology: https://510kreport.com/methodology