# K994369: 7250 (MEGAS)

- Pathway: 510(k) (Traditional)
- Applicant: Biosound Esaote, Inc.
- Decided: Feb 24, 2000 after 59 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 K944287 (1995). 2 ancestors in all.
68 later devices descend from it; 3 cite it directly.
0 of 71 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982444: 7250 Ultrasound Imaging System, Biosound Esaote, Inc. (1998) Summary page 1.

## Most influential descendants
- K040596: Ultrasound Imaging System, Model 7300 (2004), 67 descendants of its own
- K050326: 7350 Ultrasound Imaging System, Model 7350 (2005), 66 descendants of its own
- K051837: Mylab 90 Ultrasound Imaging System, Model 6100 (2005), 64 descendants of its own
- K051308: Mylab 70 Ultrasound Imaging System (2005), 64 descendants of its own
- K060827: MYLAB30, 50, 70 and 90 Systems Addition of 3D/4D, Models 7300, 7350, 6150, 6100 (2006), 62 descendants of its own

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

Source page: https://510kreport.com/device/K994369
Methodology: https://510kreport.com/methodology