# K994385: Baby Face

- Pathway: 510(k) (Traditional)
- Applicant: Sonora Medical Systems
- Decided: Mar 16, 2000 after 79 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.
4 later devices descend from it; 3 cite 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.

## 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
- K042620: Sonata 3-D Imaging Accessory, Model 3DS (2004), 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 for 3D clinical imaging in fetal applications

Source page: https://510kreport.com/device/K994385
Methodology: https://510kreport.com/methodology