# K062985: Ivus Enhancer

- Pathway: 510(k) (Traditional)
- Applicant: Indec Systems, Inc.
- Decided: Nov 22, 2006 after 54 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: 5 generations back to K941322 (1995). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022940: IN-Vision View with Measurements Module, Model 1.0, Intelligent Images Srl (2002) Summary page 1.
- K011582: Qcu Analytical Software Package, Medis Medical Imaging Systems BV (2001) Summary page 1.

## Indications for use
IVUS Enhancer is a software product intended to be used to review and analyze DICOM images, primarily intravascular ultrasound (IVUS) images. IVUS Enhancer is intended to help qualified medical professionals review DICOM images by adjusting image properties, making simple measurements, and adding annotations for easy export to other applications. These features aid in post-procedure analysis after the placement of interventional devices.

Source page: https://510kreport.com/device/K062985
Methodology: https://510kreport.com/methodology