# K052805: MYLAB30, 50 and 70 Systems Upgrade, Models 7300, 7350, 6150

- Pathway: 510(k) (Traditional)
- Applicant: Esaote, S.p.A.
- Decided: Oct 17, 2005 after 13 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: 7 generations back to K944485 (1995). 22 ancestors in all.
60 later devices descend from it; 7 cite it directly.
0 of 83 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040596: Ultrasound Imaging System, Model 7300, Esaote, S.p.A. (2004) Summary page 1.
- K050326: 7350 Ultrasound Imaging System, Model 7350, Esaote, S.p.A. (2005) Summary page 1.
- K051308: Mylab 70 Ultrasound Imaging System, Esaote, S.p.A. (2005) Summary page 1.
- K051837: Mylab 90 Ultrasound Imaging System, Model 6100, Esaote, S.p.A. (2005) Summary page 1.

## Most influential descendants
- K081794: Model 7340 Ultrasound System (2008), 57 descendants of its own
- K091009: MY LABS25 Gold/MYLAB30 Gold Cardiovascular Model 7340, MY LAB70/MY LAB70XVISION/MYLAB60, Model 6150 (2009), 51 descendants of its own
- K103152: 6250 Ultrasound Sytems (2011), 35 descendants of its own
- K133905: 6200 / 6250 Ultrasound System (2014), 34 descendants of its own
- K070903: MYLAB40 (2007), 27 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:

Source page: https://510kreport.com/device/K052805
Methodology: https://510kreport.com/methodology