# K993394: Echo Scan, Easy Scan

- 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: 2 generations back to K941322 (1995). 2 ancestors in all.
90 later devices descend from it; 2 cite it directly.
0 of 93 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963807: Tomtec Echo-Scan, Tomtec Imaging Systems, Inc. (1996) Summary page 1.

## Most influential descendants
- K020561: Sono-Scan, Sono-Scan Pro, Cardio Scan (2002), 80 descendants of its own
- K110595: 4D Sono-Scan 1.0 (2011), 79 descendants of its own
- K132544: Tomtec-Arena 1.0, Tomtec-Arena 3D Echo, Cardio-Arena (2013), 78 descendants of its own
- K150122: Tomtec-Arena TTA2 (2015), 56 descendants of its own
- K170823: Vivid E80, Vivid E90, Vivid E95 (2017), 35 descendants of its own

## Indications for use
Echo-Scan™ 4.1 is intended to acquire, store, retrieve and analyze digital ultrasound images for computerized 3-dimensional and 4-dimensional (dynamic 3D) image processing. Echo-Scan™ 4.1 can import certain digital 2D or 3D image file formats for 3D tomographic reconstructions and surface rendering. It is intended as a general purpose image acquisition and digital 3D ultrasound image processing tool for cardiology, radiology, neurology, gastro-enterology, urology, surgery, obstetrics and gynecology.

Source page: https://510kreport.com/device/K993394
Methodology: https://510kreport.com/methodology