# K963807: Tomtec Echo-Scan

- Pathway: 510(k) (Traditional)
- Applicant: Tomtec Imaging Systems, Inc.
- Decided: Dec 18, 1996 after 86 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 K941322 (1995). 1 ancestor in all.
242 later devices descend from it; 7 cite it directly.
0 of 244 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K941322: Echo-Scan, Tomographic Tech (1995) Summary page 1.

## Most influential descendants
- K992886: Powerview Ultrasound Workstation, Uidm-400A (1999), 212 descendants of its own
- K013633: Ssa-770A, Aplio Ultrasound System (2001), 211 descendants of its own
- K022400: Ssa-700A, Aplio Diagnostic Ultrasound System (2002), 210 descendants of its own
- K032281: Ssa-770A - Version 4, Aplio Diagnostic Ultrasound System (2003), 209 descendants of its own
- K063130: Aplio XG Diagnostic Ultrasound System, Model Ssa-790A, Version 1.0 (2006), 205 descendants of its own

## Indications for use
The TomTec Echo-Scan is intended to acquire, analyze, store and retrieve digital ultrasound images for computerized 3-dimensional and 4-dimensional (dynamic 3D) image processing. It is an add-on accessory for existing ultrasound imaging systems, and is intended to control position and movement of ultrasound transducers for the systematic acquisition of 2 dimensional image slices throughout a volume of interest. The Echo-Scan acquires sets of 2D images and stores them digitally in the TomTec standard 3D image file format for subsequent 3D tomographic reconstruction and surface rendering with either the Echo-Scan or Echo-View. It is intended as a general purpose digital 3D ultrasound image processing tool for cardiology, radiology, neurology, gastroenterology, urology, surgery, obstetrics and gynecology. The TomTec Freehand Scanning Device is intended for acquiring a sequence of conventional 2D ultrasound images with transducer position recorded for each image acquired. The resulting image data set is intended for storage in the TomTec standard 3D image file format for subsequent 3D tomographic image reconstruction.

Source page: https://510kreport.com/device/K963807
Methodology: https://510kreport.com/methodology