# K043111: Plaqueview Software, Model CSPV-0001A

- Pathway: 510(k) (Traditional)
- Applicant: Toshiba America Medical Systems, In.C
- Decided: Nov 18, 2004 after 8 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- 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 K945428 (1995). 4 ancestors in all.
112 later devices descend from it; 3 cite it directly.
0 of 117 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990426: Calcium Scoring, Siemens Medical Solutions USA, Inc. (1999) Summary page 1.

## Cited in the summary but kept off the family tree
- K004126: General Electric Perfusion CT 2. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree

## Most influential descendants
- K061624: Vitrea, Version 3.9 (2006), 111 descendants of its own
- K071331: Vitrea Version 4.0 (2007), 82 descendants of its own
- K073156: Qplaque MR (2008), 21 descendants of its own
- K120636: Synapse 3D Cardiac Tools (2012), 19 descendants of its own
- K092747: Philips Comprehensive Cardiac Analysis (Cca) - Plaque Assessment Tool (2009), 19 descendants of its own

## Indications for use
The PlaqueView (SurePlaque) tool kit application software package is intended to assist trained physicians in the stratification of patients identified to have coronary disease (CAD). This software post processes images obtained using a multi-detector Aquilion CT. The package provides tools for the measurement and visualization (color coded maps) of coronary arteries.

Source page: https://510kreport.com/device/K043111
Methodology: https://510kreport.com/methodology