# K070226: Cardioct

- Pathway: 510(k) (Traditional)
- Applicant: Shina Systems, Ltd.
- Decided: Mar 9, 2007 after 44 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
No predicates in its family tree.
66 later devices descend from it; 4 cite it directly.
0 of 67 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Comprehensive Cardiac Analysis (CCA) module of the "Brilliance CT, Private Practice CV configuration" CT Scanner: named in the summary without a submission number

## Most influential descendants
- K093269: Procedure Rehearsal Studio (2010), 41 descendants of its own
- K112387: Procedure Rehearsal Studio (TM) (2011), 40 descendants of its own
- K123023: Surgery Rehearsal Platform (2013), 37 descendants of its own
- K142107: Echo True 3D Viewer (2015), 27 descendants of its own
- K092747: Philips Comprehensive Cardiac Analysis (Cca) - Plaque Assessment Tool (2009), 19 descendants of its own

## Indications for use
The system, which is comprised of diagnostic reading software, is intended for use by cardiologists and radiologists as an interactive tool for viewing and analyzing cardiac CT data for determining the presence and extent of coronary obstructive disease.

Source page: https://510kreport.com/device/K070226
Methodology: https://510kreport.com/methodology