# K013088: Echotech Easy 3D Family, Echotech 3D Freescan, Echotech Easyarchive, Echotech Quanticon, Echotech Easystress

- Pathway: 510(k) (Traditional)
- Applicant: Echotech 3D Imaging Systems, Inc.
- Decided: Apr 4, 2002 after 199 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: 3 generations back to K941322 (1995). 3 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980308: Echotech 3D Freescan, Echotech 3D Imaging Systems GmbH (1998) Summary page 2.
- K963807: Tomtec Echo-Scan, Tomtec Imaging Systems, Inc. (1996) Summary page 2.

## Most influential descendants
- K030635: The Obsidian Pacs System (2003), 1 descendant of its own
- K060035: Mdxnet (2006), 0 descendants of its own
- K031567: 3D Invivo by Csist (2003), 0 descendants of its own

## Indications for use
The EchoTech Easy3D is indicated for acquisition of related sets of 2D ultrasound images and 3D reconstruction of ultrasound images. It is intended to acquire, analyze, store, and retrieve digital ultrasound images for computerized 3D image processing. Easy3D is an add-on accessory to existing diagnostic ultrasound systems. Easy3D employs freehand scanning without the use of a coordinate and position sensor, therefore, the extension of the data set in the scanning direction is unknown. The images are not intended for use in diagnosis or quantitative measurements. The Easy3D is intended as a general purpose digital 3D ultrasound image processing tool for use in obstetrics for qualitative evaluation of deformities and determination of the need for further fetal ultrasound studies. The EchoTech 3D FreeScan system is indicated for acquisition of related sets of 2D ultrasound images and 3D reconstruction of ultrasound images. It is intended to acquire, analyze, store, and retrieve digital ultrasocund images for computerized 3D image processing. Easy3D is an add-on accessory to existing diagnostic ultrasound systems. Easy3D employs freehand scanning with the use of a coordinate and position sensor and, optionally, with heart cycle (R-Peak) triggering, which enables cardiovascular imaging. The EchoTech EasyArchive system is indicated to acquire, digitize, archive, and retrieve single or sequences of 2D ultrasound images. EasyArchive is an add-on accessory to existing diagnostic ultrasound systems. EasyArchive is intended as a general purpose digital ultrasound image processing and archiving tool for use in radiology, neurology, gastroenterology, urology, surgery, orthopedics, cardiology, oncology, obstetrics and gynecology. The EchoTech Quanticon is indicated in the acquisition of either heart cycle (R-Peak) triggered or nontriggered sequences of 2D ultrasound images for use in the evaluation of contrast agent-based ultrasound exams. In the sequence of images multiple Regions Of Interest (ROIl) can be selected. Inside these chosen regions the average gray value or the number of color pixels is calculated over time. Quanticon is intended an add-on accessory to existing diagnostic ultrasound systems. Quanticon is intended as a general digital ultrasound processing and archiving tool for use in cardiology, radiology, and neurology. The EchoTech EasyStress system is indicated for the acquisition of heart cycle (R-Peak) triggered sequences of 2D ultrasound images for use in performing, scoring, measuring, reporting, and archiving stress echo studies. The EasyStress system utilizes the ASE Standard for Wall Motion Scoring to quantify wall motion abnormalities of the heart. EasyStress is an add-on accessory to existing diagnostic ultrasound systems. EasyStress is a digital ultrasound image processing and archiving tool for use in cardiology.

Source page: https://510kreport.com/device/K013088
Methodology: https://510kreport.com/methodology