# K042620: Sonata 3-D Imaging Accessory, Model 3DS

- Pathway: 510(k) (Traditional)
- Applicant: Tetrad Corp.
- Decided: Dec 23, 2004 after 87 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). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K994385: Baby Face, Sonora Medical Systems (2000) Summary page 1.

## Indications for use
Intended to be used by or under the direction of a physician for 3-D clinical imaging in fetal applications. This is only to be used in conjunction with the 2300 Ultrasound Imaging system marketed under the model name 'Sonata' or 'Telocin', labeled as 2300 Ultrasound Imaging System manufactured by Tetrad Corporation.

Source page: https://510kreport.com/device/K042620
Methodology: https://510kreport.com/methodology