# K062059: Aie Region of Interest Image Enhancement

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Image Enhancement
- Decided: Sep 6, 2006 after 48 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 K913770 (1991). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041555: Securview DX Softcopy Workstation, Hologic, Inc. (2004) Summary page 1.

## Indications for use
The Advance Image Enhancement, Inc.'s Region of Interest Image Enhancement software is intended to improve the sharpness and clarity of subtle image features, The device used with FDA cleared monitors may be used by a trained physician or healthcare professional for display, manipulation and interpretation of lossless compressed or non-compressed mammographic images for screening and diagnostic mammography, as well as any other DICOM multi-modality image. The AlE software is intended as an added tool residing on any DICOM image workstation for improving the radiologist's perception of image features on any lossless compressed or non-compressed multi-modality DICOM 'for-presentation" image. This software Would be used while the radiologist is reviewing magnification window image segments on FDA cleared monitors and is intended to complement existing DICOM image workstation functionality. Warning: Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA,

Source page: https://510kreport.com/device/K062059
Methodology: https://510kreport.com/methodology