# K022824: Echo-View 5.X, Easy-View 2.X, Omni View 2.X, Cardio-View 1.X, LV Analysis 1.X & Surgical View 1.X

- Pathway: 510(k) (Special)
- Applicant: Tomtec Imaging Systems GmbH
- Decided: Oct 17, 2002 after 52 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: 2 generations back to K934139 (1995). 2 ancestors in all.
986 later devices descend from it; 4 cite it directly.
8 of 989 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993398: Echo View, Easy View, Omni View, Tomtec Imaging Systems GmbH (1999) Summary page 1.

## Most influential descendants
- K042540: Philips IU22 Ultrasound System (2004), 882 descendants of its own
- K093563: IU22 Ultrasound System and Transducers (2010), 588 descendants of its own
- K102041: Aixplorer (2010), 527 descendants of its own
- K112255: Aixplorer (2012), 525 descendants of its own
- K121329: Aixplorer (2012), 405 descendants of its own

## Indications for use
The products: Echo-View 5.x Easy-View 2.x Omni View 2.x Cardio-View 1.x LV Analysis 1.x Surgical View 1.x are intended to retrieve, analyze and store digital ultrasound images and Color Doppler images for computerized 3-dimensional and 4-dimensional (dynamic 3D) image processing. Echo-View 5.x , Easy-View 2.x, Omni-View 2.x, Cardio-View 1.x, LV Analysis 1.x and Surgical View 1.x can import certain digital 2D or 3D image file formats for 3D tomographic reconstructions and surface rendering. It is intended as a general purpose digital 3D ultrasound image processing tool for cardiology, radiology, neurology, gastro-enterology, urology, surgery, obstetrics and gynecology.

Source page: https://510kreport.com/device/K022824
Methodology: https://510kreport.com/methodology