# K012084: Sonoreal 3D

- Pathway: 510(k) (Traditional)
- Applicant: Bio Medi Com
- Decided: Sep 26, 2001 after 85 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 1.

## Most influential descendants
- K020068: Sonoreal 3D System (2002), 2 descendants of its own
- K023473: Sonoreal 3D (2002), 1 descendant of its own
- K053306: IVIEW (2006), 0 descendants of its own

## Indications for use
Intended to be used by or under the direction of a physician and in conjunction with standard ultrasound system to provide 3D clinical imaging in fetal and gynecological applications. The SONOReal™ system does not currently provide any quantitative measurement capabilities or diagnostic interpretations. It is intended to visualize features that you may wish to examine more closely in routine 2D ultrasound diagnostic imaging examinations.

Source page: https://510kreport.com/device/K012084
Methodology: https://510kreport.com/methodology