# K031552: Mycolor 202 Diagnostic Ultrasound System and Transducers

- Pathway: 510(k) (Traditional)
- Applicant: Medison America, Inc.
- Decided: May 30, 2003 after 11 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K924432 (1993). 12 ancestors in all.
184 later devices descend from it; 2 cite it directly.
0 of 197 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 9.
- K013627: Sonoace SA-8000 Diagnostic Ultrasound System, Medison America, Inc. (2001) Summary page 9.

## Most influential descendants
- K043455: SA8000 SE Diagnostic Ultrasound System (2004), 182 descendants of its own
- K061213: Sonoace Pico Diagnostic Ultrasound System (2006), 114 descendants of its own
- K100186: Mysono U5 Diagnostic Ultrasound System (2010), 111 descendants of its own
- K102065: Sonoace R7 Diagnostic Ultrasound System (2010), 110 descendants of its own
- K112646: Sonoace R7 Diagnostic Ultrasound System (2011), 108 descendants of its own

## Recalls of this device
- Aug 12, 2008 · Not classified · Z-0523-2009: The system has a software defect that affects the display of Estimated Fetal Weight (EFW) Growth Percentile result values.
- Aug 12, 2008 · Not classified · Z-0522-2009: The system has a software defect that affects the display of Estimated Fetal Weight (EFW) Growth Percentile result values.
- May 29, 2008 · Not classified · Z-2013-2008: HD3 Biopsy Guide Kits do not contain adequate labeling instructions for safe and effective use.
- May 29, 2008 · Not classified · Z-2015-2008: HD3 Biopsy Guide Kits do not contain adequate labeling instructions for safe and effective use.
- May 29, 2008 · Not classified · Z-2014-2008: HD3 Biopsy Guide Kits do not contain adequate labeling instructions for safe and effective use.

## Indications for use
mycolor 202 intended uses as defined FDA guidance documents are: Fetal (includes infertility monitoring of follicle development) Abdominal Pediatric Small Organ Cardiac (Adult) Trans-Rectal Trans-Vaginal Peripheral-Vascular Muscular-Skeletal (conventional, superficial)

Source page: https://510kreport.com/device/K031552
Methodology: https://510kreport.com/methodology