# K043360: Imt.Lab

- Pathway: 510(k) (Traditional)
- Applicant: Pie Medical
- Decided: Jan 5, 2005 after 29 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: 2 generations back to K021966 (2002). 2 ancestors in all.
22 later devices descend from it; 3 cite it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

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

## Most influential descendants
- K061961: Art Lab Software (2006), 18 descendants of its own
- K153277: 6200 Ultrasound System and 6250 Ultrasound System (2016), 12 descendants of its own
- K163082: 6200 Ultrasound System and 6250 Ultrasound System (2017), 9 descendants of its own
- K173291: 6440 Ultrasound System (2018), 8 descendants of its own
- K230179: 6440 MyLabX90 (2023), 4 descendants of its own

## 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 Pie ultrasound systems.

Source page: https://510kreport.com/device/K043360
Methodology: https://510kreport.com/methodology