# K993398: Echo View, Easy View, Omni View

- Pathway: 510(k) (Special)
- Applicant: Tomtec Imaging Systems GmbH
- Decided: Nov 5, 1999 after 28 days
- Product code: IYO (System, Imaging, Pulsed Echo, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K934139 (1995). 1 ancestor in all.
987 later devices descend from it; 1 cites 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)
- K934139: Tomtec Echo-View, Tomtec Tomographic Technologies GmbH (1995) Summary page 1.

## Most influential descendants
- 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 (2002), 986 descendants of its own
- 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

## Indications for use
Echo-View™ 4.X is intended to retrieve, analyze and store digital ultrasound images for computerized 3-dimensional and 4-dimensional (dynamic 3D) image processing. Echo-View™ 4.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, gastroenterology, urology, surgery, obstetrics and gynecology.

Source page: https://510kreport.com/device/K993398
Methodology: https://510kreport.com/methodology