# K070244: AEGIS

- Pathway: 510(k) (Traditional)
- Applicant: Sentinelle Medical, Inc.
- Decided: Feb 9, 2007 after 15 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). 8 ancestors in all.
89 later devices descend from it; 2 cite it directly.
0 of 98 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043216: Cadstream Version 4.0, Confirma, Inc. (2005) Summary page 1.

## Most influential descendants
- K093462: Sonix Ultrasound Scanner (2009), 79 descendants of its own
- K102997: Sonixtablet Ultrasound Scanner (2010), 77 descendants of its own
- K113663: Sonixtablet Ultrasound Scanner (2012), 75 descendants of its own
- K123001: Acuson X700 Diagnstic Ultrasound System (2012), 74 descendants of its own
- K132804: Acuson S1000 / S2000 / S3000 (2013), 73 descendants of its own

## Indications for use
Aegis is a software application intended for use in analyzing magnetic resonance imaging (MRI) medical images as well as other modality images. Aegis includes software to support the use of interventional breast coils and MR fiducial localization devices to perform MR-guided breast interventional procedures (BRIGHTS). Its primary goal is to identify where and how deep a biopsy or localization needle should be inserted into an imaged breast in order to strike a targeted lesion or region of interest, as chosen by a trained medical professional. Aegis receives images and data from various sources (including CT, MR, US, computed and direct radiographic devices, secondary capture devices, scanners, imaging gateways and imaging sources). Aegis can be used to communicate. process, and display medical images. Users have access to various image processing and measurement tools to assist them in viewing images. These user-defined post-processing functions include image subtractions, multiplanar reformats, maximum intensity projections, and segmenting of regions based on enhancement characteristics. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using a FDA approved monitor that offers at least 5 MPixel resolution and meets other technical specifications reviewed and accepted by the FDA. Typical users of Aegis are trained medical professionals, including radiologists, technologists and clinicians. When interpreted by a skilled user, this device provides information that may be useful in screening and diagnosis. Patient management decisions should not be made solely on the results of Aegis analysis.

Source page: https://510kreport.com/device/K070244
Methodology: https://510kreport.com/methodology