# K013627: Sonoace SA-8000 Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Medison America, Inc.
- Decided: Nov 16, 2001 after 11 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: 4 generations back to K924432 (1993). 11 ancestors in all.
204 later devices descend from it; 6 cite it directly.
0 of 216 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002185: Sonoace SA 9900 Diagnostic Ultrasound System, Medison America, Inc. (2000) Summary page 2.
- K974269: SA8800 Diagnostic Ultrasound System and Transducers,, Medison America, Inc. (1998) Summary page 2.

## Most influential descendants
- 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
- K032329: SA 9900 Plus Diagnostic Ultrasound System (2003), 132 descendants of its own
- K052911: Accuvix XQ Diagnostic Ultrasound System (2005), 131 descendants of its own
- K063580: Sonoace X8 Diagnostic Ultrasound System (2006), 129 descendants of its own

## Indications for use
SA8000 intended uses as defined FDA guidance documents are: Fetal (includes infertility monitoring of follicle development) Abdominal Pediatric Small Organ Neonatal Cephalic Adult Cephalic Cardiac (Adult, Pediatric) Trans-Rectal Trans-Vaginal Peripheral-Vascular Muscular-Skeletal (conventional, superficial) Intra-Operative (Neurological, Abdominal, Peripheral vascular) Typical examinations performed using the system are: General abdominal and pelvic studies including organ surveys, assessment, and retroperitoneal cavity studies. Study of small parts including breasts, shoulders, thyroid, and the abdominal wall. Pediatric scans of organs and bony structures. Peripheral vascular applications including carotid arteries, legs, arms, feet, and penile artery. Monitoring procedures for infertility studies (other than in vitro fertilization). First, second and third trimester pregnancy studies. Prostate, prostate biopsy guidance, and rectal wall studies. Neonatal head studies. Trans-cranial studies of middle cerebral arteries, internal carotid artery, and vertebral arteries. Cardiac studies in adults and children. Biopsy guidance for tissue or fluid sampling. Conventional podiatry scans.

Source page: https://510kreport.com/device/K013627
Methodology: https://510kreport.com/methodology