# K041675: Picus, Parus, Falco and Aquila Ultrasound Systems

- Pathway: 510(k) (Traditional)
- Applicant: Pie Medical
- Decided: Jul 23, 2004 after 32 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: 2 generations back to K000931 (2000). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023512: Picus Ultrasound Imaging Systems, Pie Medical (2003) Summary page 1.
- K002880: 300LC Ultrasound Imaging Systems, Model 300LC, Pie Medical (2000) Summary page 1.
- K003725: 240 Parus Ultrasound Imaging Systems, Model 240 Parus, Pie Medical (2001) Summary page 1.
- K002357: 100 S and 100 LC and 485 Anser Ultrasound Imaging Systems, Pie Medical (2000) Summary page 1.
- K022928: Hudson 2020, 2040, 2060,Ultrasound Scanners, Hudson Diagnostic Imaging, LLC (2002) Summary page 1.

## Indications for use
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Source page: https://510kreport.com/device/K041675
Methodology: https://510kreport.com/methodology