# K023100: Accusketch Cardiac Quantitative System W/ Advanced Analysis Components

- Pathway: 510(k) (Special)
- Applicant: General Electric Medical Systems Information Techn
- Decided: Oct 11, 2002 after 23 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 K842308 (1984). 5 ancestors in all.
23 later devices descend from it; 2 cite it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K912829: Cardiotrace Cardiac Evaluation Systems, Cine Graphics, Inc. (1991) Summary page 1.
- K992637: Muse Cardiovascular Information System, General Electric Medical Systems Information Techn (1999) Summary page 1.

## Most influential descendants
- K042525: Centricity Radiology RA600/Centricity Cardiology CA1000/Centricity Digital Hardcopy Workstation (2004), 22 descendants of its own
- K063628: Centricity Radiology RA600, Cardiology CA1000 and Digital Hardcopy (2006), 18 descendants of its own
- K081018: Syngo Dynamics Version 7.0 (2008), 8 descendants of its own
- K102150: Syngo Dynamics, Version 9.0 (2010), 7 descendants of its own
- K123922: Syngo Dynamics (2013), 5 descendants of its own

## Indications for use
AccuSketch Cardiac Quantitative Analysis System w/ Advanced Analysis Components is intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use. AccuSketch is intended to provide and document an objective quantification of coronary artery stenosis and measurement and quantification of left ventricular function. Also provided is the ability to digitize and store video images and the ability to interactively annotate and report current and post procedural patient cardiac status.

Source page: https://510kreport.com/device/K023100
Methodology: https://510kreport.com/methodology