# K974813: Combison 530D with Power Doppler Mode

- Pathway: 510(k) (Traditional)
- Applicant: Medison America, Inc.
- Decided: Sep 29, 1998 after 280 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K933743 (1994). 1 ancestor in all.
211 later devices descend from it; 3 cite it directly.
0 of 213 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K933743: SSA-380A, Toshiba America Medical Systems, In.C (1994) Summary page 1.

## Most influential descendants
- K992155: Volusion Small Parts Transducer, Model S-VNW 5-10, Volusion Abdominal Transducer, Model S-Vaw 4-7 (1999), 208 descendants of its own
- K002185: Sonoace SA 9900 Diagnostic Ultrasound System (2000), 207 descendants of its own
- K013627: Sonoace SA-8000 Diagnostic Ultrasound System (2001), 204 descendants of its own
- K031552: Mycolor 202 Diagnostic Ultrasound System and Transducers (2003), 184 descendants of its own
- K043455: SA8000 SE Diagnostic Ultrasound System (2004), 182 descendants of its own

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

Source page: https://510kreport.com/device/K974813
Methodology: https://510kreport.com/methodology