# K982444: 7250 Ultrasound Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: Biosound Esaote, Inc.
- Decided: Oct 6, 1998 after 84 days
- Product code: IYO (System, Imaging, Pulsed Echo, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1560
- 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 K944287 (1995). 1 ancestor in all.
69 later devices descend from it; 5 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)
- K944287: 7050 Ultrasound Imaging System, Biosound, Inc. (1995) Summary page 1.

## Most influential descendants
- K994369: 7250 (MEGAS) (2000), 68 descendants of its own
- 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

## 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: 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/K982444
Methodology: https://510kreport.com/methodology