# K093672: Aegis Navigation Anda Egis Pelvic Application

- Pathway: 510(k) (Traditional)
- Applicant: Sentinelle Medical, Inc.
- Decided: Dec 11, 2009 after 14 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: 6 generations back to K913770 (1991). 68 ancestors in all.
8 later devices descend from it; 2 cite it directly.
6 of 77 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081093: 3-D Imaging Workstation, Eigen, LLC (2008) Summary page 2.
- K070244: AEGIS, Sentinelle Medical, Inc. (2007) Summary page 2.
- K053610: Abaris, Traxtal Technologies, Inc. (2006) Summary page 2.

## Most influential descendants
- K120187: Multi-Modality Image Fusion (2012), 4 descendants of its own
- K161109: iSR'obot MRI-US Fusion (2016), 2 descendants of its own
- K123901: Tractus Tissuemapper Reviewer Application (2013), 2 descendants of its own
- K213411: iSR’obot Mona Lisa 2.0 (2021), 1 descendant of its own
- K171709: BR-FHUS Viewer 1.0 (2017), 1 descendant of its own

## Indications for use
This device provides two and three-dimensional image review, manipulation, and analysis tools to assist users in screening, diagnosis, planning and performing image-guided interventional procedures. Supported imaging modalities include Magnetic Resonance (MR), Ultrasound (US), Single Photon Emission Computed Tomography (SPECT), Computed Tomography (CT), Positron Emission Tomography (PET), Fluoroscopy and Endoscopy. Images and data are received from various imaging systems and other sources such as calibrated spatial positioning devices. This device provides the capability to overlay annotations on 2D or 3D medical image displays. These annotations may represent the position of instruments including but not limited to biopsy needles, guidance wires, imaging probes or other tracked devices. This device is intended to assist skilled medical professionals in clinical screening and interventions, for anatomical structures where imaging is currently used for visualizing such structures, including head and neck, breast, thoracic, and abdominal applications (including pelvis). 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.

Source page: https://510kreport.com/device/K093672
Methodology: https://510kreport.com/methodology