# K083877: Flying Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Neusoft Medical Systems Co., Ltd.
- Decided: Jan 13, 2009 after 15 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: 2 generations back to K961459 (1997). 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)
- K014191: M2540 Diagnostic Ultrasound System, Model M2540, Philips Medical Systems (2002) Summary page 6.
- K030455: Boris Platform Diagnostic Ultrasound System, Philips Ultrasound, Inc. (2003) Summary page 1.

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

Source page: https://510kreport.com/device/K083877
Methodology: https://510kreport.com/methodology