# K023512: Picus Ultrasound Imaging Systems

- Pathway: 510(k) (Traditional)
- Applicant: Pie Medical
- Decided: Jan 24, 2003 after 95 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 K000931 (2000). 2 ancestors in all.
32 later devices descend from it; 2 cite it directly.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002880: 300LC Ultrasound Imaging Systems, Model 300LC, Pie Medical (2000) Summary page 3.
- K000931: AU5 Ultrasound Imaging System, Biosound Esaote, Inc. (2000) Summary page 3.

## Most influential descendants
- K043588: Mylab 15 / Mylab 20, Model 2700 (2005), 30 descendants of its own
- K053154: MYLAB15/20 3D/4D Ultrasound Imaging System (2005), 29 descendants of its own
- K061755: MYLAB15/20 New Indications Ultrasound System (2006), 28 descendants of its own
- K070903: MYLAB40 (2007), 27 descendants of its own
- K083882: Mylabfive (2009), 26 descendants of its own

## Indications for use
Pie Medical’s Picus 3D ultrasound system is intended to be used by a physician to perform general diagnostic ultrasound studies including cardiac, peripheral vascular, fetal, abdominal, small organ, neonatal cephalic, transrectal and transvaginal.

Source page: https://510kreport.com/device/K023512
Methodology: https://510kreport.com/methodology