# K062598: Imt.Lab Software

- Pathway: 510(k) (Traditional)
- Applicant: Esaote Europe B.V.
- Decided: Oct 31, 2006 after 60 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K021966 (2002). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043360: Imt.Lab, Pie Medical (2005) Summary page 1.
- K030223: Sonocalc, Sonometric Health, LLC (2003) Summary page 1.
- K021966: Q Lab Software, Advanced Technology Laboratories, Inc. (2002) Summary page 1.

## Indications for use
The IMT.LAB software is a Windows 2000/XP software application package to be used on a personal computer for the automatic measurement of the intima media thickness of the carotid artery from video images obtained from Esaote ultrasound systems.

Source page: https://510kreport.com/device/K062598
Methodology: https://510kreport.com/methodology