# K020068: Sonoreal 3D System

- Pathway: 510(k) (Traditional)
- Applicant: Bio Medi Com
- Decided: Mar 4, 2002 after 54 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: 4 generations back to K941322 (1995). 5 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 8 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.
- K994385: Baby Face, Sonora Medical Systems (2000) Summary page 1.
- K012084: Sonoreal 3D, Bio Medi Com (2001) Summary page 1.

## Most influential descendants
- 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 a standard ultrasound system to provide 3D and Multi-planar clinical imaging in fetal and gynecological applications. SONOReal™ is intended to visualize features that the user may wish to examine more closely in routine 2D ultrasound diagnostic imaging examinations. The user is offered the capability to perform linear, area and volumetric measurements of the subject being scanned. SONOReal™ does not provide any diagnostic interpretations.

Source page: https://510kreport.com/device/K020068
Methodology: https://510kreport.com/methodology