# K030223: Sonocalc

- Pathway: 510(k) (Traditional)
- Applicant: Sonometric Health, LLC
- Decided: Feb 6, 2003 after 15 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K021966 (2002). 1 ancestor in all.
146 later devices descend from it; 6 cite it directly.
0 of 148 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021966: Q Lab Software, Advanced Technology Laboratories, Inc. (2002) Summary page 2.

## Most influential descendants
- K040686: M'ath STD (2004), 122 descendants of its own
- K121223: Qlab with FHN and VPQ Plug-in (2012), 98 descendants of its own
- K162094: RS80A Diagnostic Ultrasound System (2016), 64 descendants of its own
- K163691: HS70A Diagnostic Ultrasound System (2017), 58 descendants of its own
- K171048: RS80A Diagnostic Ultrasound System (2017), 50 descendants of its own

## Recalls of this device
- Oct 26, 2005 · Not classified · Z-0713-06: When SonoCalc IMT 3.0 software is used with the SonoSite 180Plus ultrasound system, the software miscalculates the intima-media-thickness, a measurement of risk for cardiovascular or cerebrovascular e

## Indications for use
The SonoCalc software is a Windows-based application program used on a personal computer for the automatic measurement of the intima media thickness of the carotid artery from images obtained from ultrasound systems.

Source page: https://510kreport.com/device/K030223
Methodology: https://510kreport.com/methodology