# K090059: Imago C21 Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Saset (Chengdu), Inc.
- Decided: Apr 30, 2009 after 111 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: 3 generations back to K935595 (1995). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K014116: Hand-Carried Ultrasound System, Sonosite,Inc. (2001) Summary page 2.
- K020630: Ultrasonix Ergosonix 500 Ultrasound Scanner, Ultrasonix Medical Corporation (2002) Summary page 2.

## Most influential descendants
- K150002: iNSIGHT Color Doppler Ultrasound System (2015), 0 descendants of its own

## Indications for use
The iMago c21 medical ultrasound system is intended for visualization of internal organs and for medical diagnostic purposes only. The main applications are: General radiology, Abdominal (excluding fetal Doppler), Vascular, OB/GYN, Urology, Breast, Superficial Organ (Small Parts), Musculoskeletal, and Cardiology. Each application includes a set of exams, including the specific measurements, reports, pictograms, annotations and system presets.

Source page: https://510kreport.com/device/K090059
Methodology: https://510kreport.com/methodology