# K984639: The S-Vna 5-8(B) Diagnostic Ultrasound Transducer

- Pathway: 510(k) (Traditional)
- Applicant: Medison America, Inc.
- Decided: Jul 12, 1999 after 193 days
- Product code: ITX (Transducer, Ultrasonic, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 892.1570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K961459 (1997). 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)
- K974813: Combison 530D with Power Doppler Mode, Medison America, Inc. (1998) Summary page 1.
- K974269: SA8800 Diagnostic Ultrasound System and Transducers,, Medison America, Inc. (1998) Summary page 2.

## Indications for use
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Source page: https://510kreport.com/device/K984639
Methodology: https://510kreport.com/methodology