# K082224: Diagnostic Ultrasound System Sarano, Echo View, Shimasonic

- Pathway: 510(k) (Traditional)
- Applicant: Shimadzu Medical Systems
- Decided: Dec 15, 2008 after 131 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: 5 generations back to K933202 (1994). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061641: Echo View/Shimasonic Diagnostic Ultrasound System, Model Sarano, Shimadzu Medical Systems (2006) Summary page 1.

## Indications for use
Diagnostic ultrasound imaging or Doppler analysis of the human body as follows: Fetal, Abdominal, Pediatric, Small Organs (Specify), Neonatal Cephalic, Adult Cephalic, Cardiac, Transrectal, Transvaginal, Peripheral Vascular, Musculo-skeletal Superficial and Musculo-skeletal Conventional. Other Indications or Modes: · Thyroid, Testicles, Breast · * B/M

Source page: https://510kreport.com/device/K082224
Methodology: https://510kreport.com/methodology