# K042042: Ultrasound Capture System

- Pathway: 510(k) (Abbreviated)
- Applicant: Heartlab, Inc.
- Decided: Sep 21, 2004 after 54 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- 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 K950279 (1995). 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)
- K992259: Echocardiography System Series 95000, Camtronics, Ltd. (1999) Summary page 2.

## Cited in the summary but kept off the family tree
- K990857: CineCapture System. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 2.

## Indications for use
The Ultrasound Capture SystemTM (UCS) system captures analog video and audio from any ultrasound with a composite or S-video output and converts the captured video to DICOM image and audio files. UCS software runs on a standard "off-the-shelf' personal computer running the Windows XP operating system and a high-resolution video acquisition interface.

Source page: https://510kreport.com/device/K042042
Methodology: https://510kreport.com/methodology