# K980308: Echotech 3D Freescan

- Pathway: 510(k) (Traditional)
- Applicant: Echotech 3D Imaging Systems GmbH
- Decided: May 6, 1998 after 99 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.
10 later devices descend from it; 5 cite it directly.
0 of 13 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 2.

## Most influential descendants
- K994385: Baby Face (2000), 4 descendants of its own
- K013088: Echotech Easy 3D Family, Echotech 3D Freescan, Echotech Easyarchive, Echotech Quanticon, Echotech Easystress (2002), 3 descendants of its own
- K012084: Sonoreal 3D (2001), 3 descendants of its own
- K020068: Sonoreal 3D System (2002), 2 descendants of its own
- K030635: The Obsidian Pacs System (2003), 1 descendant of its own

## Indications for use
The ECHOTECH 3D FreeScan system is indicated for acquisition of related sets of 2D ultrasound images and 3 dimensional reconstruction of diagnostic ultrasound images. It is intended to acquire, analyze, store and retrieve digital ultrasound images for computerized 3-dimensional image processing. It is an add-on accessory for existing ultrasound imaging systems, and is intended to record position and movement of ultrasound transducers for the systematic acquisition of 2 dimensional image slices throughout a volume of interest. It is intended as a general purpose digital 3D ultrasound image processing tool for radiology, neurology, gastroenterology, urology, surgery, orthopedics, oncology, obstetrics and gynecology.

Source page: https://510kreport.com/device/K980308
Methodology: https://510kreport.com/methodology