# K061961: Art Lab Software

- Pathway: 510(k) (Traditional)
- Applicant: Pie Medical
- Decided: Sep 6, 2006 after 57 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 K954022 (1996). 11 ancestors in all.
18 later devices descend from it; 2 cite it directly.
0 of 30 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.
- K961144: MS-2000, Touritu Engineering Co., Inc. (1997) Summary page 1.
- K032875: Aloka Model SSD-5500 V6.0 Ultrasound System, Aloka Co. Ltd USA (2003) Summary page 1.

## Most influential descendants
- 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
- K192157: 6450 Ultrasound system (2019), 4 descendants of its own

## Indications for use
ART.LAB is a software package to be used on an external personal computer for the real time automatic measurement of the Intima Media Thickness, diameter and distension of the carotid artery from RF based signal processing obtained from Esaote or Pie Medical ultrasound systems. The Arterial Stiffness Indicator is calculated froM distension and blood pressure (systolic and diastolic).

Source page: https://510kreport.com/device/K061961
Methodology: https://510kreport.com/methodology