510(k) · Cleared
ClearedAegis Navigation Anda Egis Pelvic Application
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sentinelle Medical, Inc. · LLZ System, Image Processing, Radiological
Cleared on Dec 11, 2009 as substantially equivalent to K081093 (Eigen, LLC, 2008) and 2 other predicates after a 14-day review. Its family tree reaches back 6 generations to 1991. 6 of the 77 devices in its family, counting itself, have a Class I recall. 8 later devices descend from it.
- Decided
- Dec 11, 2009
- Review
- 14 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K913770 (1991). 68 ancestors in all, the oldest K882383 (1988). 8 later devices descend from it, 2 citing it directly. 6 of the 77 devices in this family, counting this one, have a Class I recall.
- Root · 6 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 5 generations backK960613 GE Advantage Windows Review WorkstationGE Medical Systems · 1996
- 4 generations backK020483 Advantage Workstation 4.1GE Medical Systems · 2002 · Recalled
- 3 generations backK033400 Seno AdvantageGe Medical Systems W-400 · 2003 · Recalled
- 2 generations backK043216 Cadstream Version 4.0Confirma, Inc. · 2005
- 1 generation backK070244 AEGISSentinelle Medical, Inc. · 2007
- This deviceK093672 Aegis Navigation Anda Egis Pelvic ApplicationSentinelle Medical, Inc. · 2009
- Descendant · cites it directly · 4 of its ownK120187 Multi-Modality Image FusionIgt, LLC Dba Eigen · 2012
- Descendant · 2 generations on · 2 of its ownK161109 iSR'obot MRI-US FusionBiobot Surgical Pte., Ltd. · 2016
- Descendant · cites it directly · 2 of its ownK123901 Tractus Tissuemapper Reviewer ApplicationTractus Corporation · 2013
- Descendant · 3 generations on · 1 of its ownK213411 iSR’obot Mona Lisa 2.0Biobot Surgical Pte., Ltd. · 2021
- Descendant · 2 generations on · 1 of its ownK171709 BR-FHUS Viewer 1.0Taihao Medical, Inc. · 2017
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 8 · See all- K120187Multi-Modality Image FusionIgt, LLC Dba Eigen · 2012 · cites it directly4descendants
- K161109iSR'obot MRI-US FusionBiobot Surgical Pte., Ltd. · 2016 · 2 generations on2descendants
- K123901Tractus Tissuemapper Reviewer ApplicationTractus Corporation · 2013 · cites it directly2descendants
- K213411iSR’obot Mona Lisa 2.0Biobot Surgical Pte., Ltd. · 2021 · 3 generations on1descendant
- K171709BR-FHUS Viewer 1.0Taihao Medical, Inc. · 2017 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −5 | K960613 | GE Advantage Windows Review Workstation | GE Medical Systems | 1996 | — |
| −4 | K020483 | Advantage Workstation 4.1 | GE Medical Systems | 2002 | 2 |
| −3 | K033400 | Seno Advantage | Ge Medical Systems W-400 | 2003 | 6 |
| −2 | K043216 | Cadstream Version 4.0 | Confirma, Inc. | 2005 | — |
| −1 | K070244 | AEGIS | Sentinelle Medical, Inc. | 2007 | — |
| 0 (this device) | K093672 | Aegis Navigation Anda Egis Pelvic Application | Sentinelle Medical, Inc. | 2009 | — |
| +1 | K120187 | Multi-Modality Image Fusion | Igt, LLC Dba Eigen | 2012 | — |
| +2 | K161109 | iSR'obot MRI-US Fusion | Biobot Surgical Pte., Ltd. | 2016 | — |
| +1 | K123901 | Tractus Tissuemapper Reviewer Application | Tractus Corporation | 2013 | — |
| +3 | K213411 | iSR’obot Mona Lisa 2.0 | Biobot Surgical Pte., Ltd. | 2021 | — |
| +2 | K171709 | BR-FHUS Viewer 1.0 | Taihao Medical, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 5 | 1 |
| 1997 | 2 | 0 |
| 1998 | 10 | 3 |
| 1999 | 5 | 0 |
| 2000 | 7 | 1 |
| 2001 | 7 | 0 |
| 2002 | 7 | 0 |
| 2003 | 5 | 0 |
| 2004 | 2 | 1 |
| 2005 | 3 | 0 |
| 2006 | 2 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2021 | 2 | 0 |
| 2023 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
6 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LLZ device
- #1 K230955 syngo Application Softwarescore 21.5 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K081093 | 3-D Imaging WorkstationSummary page 2…tantially equivalent to: Device Name: Elgen 3D-lmaging Workstation Manufacturer: jEigen LLC 510(k) Number: jK081093 Decision Date:j May 1, 2008 Decision: {Substantially Equivalent Device Name:… | 2008 |
| * | K070244 | AEGISSummary page 2…stantially Equivalent Device Name: Aegis Manufacturer: Sentinelle Medical Inc. 510(k) Number:j K070244 Decision Date:J Februarv 9, 2007 Decision:j Substantially Equivalent Device N… | 2007 |
| * | K053610 | AbarisSummary page 2…Substantially Equivalent Device Name: Abaris Manufacturer: Traxtal Inc. 510(k) Number: K053610 Page 2 of 10 sentinelle 510 (k) Premarket Notifica… | 2006 |
What descends from it? (8)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (6 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K040050Instatrak System with Multiple Dataset Navigation, Model IT3500Ge Medical Systems Navigation and Visualization IN · 2004 · 2 generations back · ◆ in the 2004 ancestors bar of FIG. 11 Class I recall
- K994270Instatrak 3000 System with Fluorotrak Module, Model IT3000Visualization Technology, Inc. · 2000 · 2 generations back · ◆ in the 2000 ancestors bar of FIG. 12 Class I recalls
- K983529Instatrak 3000Visualization Technology, Inc. · 1998 · 2 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K982994Skull Base Instatrak SystemVisualization Technology, Inc. · 1998 · 2 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K981998Pediatric Instatrak SystemVisualization Technology, Inc. · 1998 · 2 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K960330InstatrakVisualization Technology, Inc. · 1996 · 2 generations back · ◆ in the 1996 ancestors bar of FIG. 11 Class I recall
Nearest 5 of 6; all are on the web page.
What does this lineage say?
- The line of descent spans 18 years and passes through 5 companies; a new generation was cleared every 2.8 years on median.
- 23 of the 68 ancestors have a recall of any class; 6 have a Class I recall.
- Of its descendants, K120187 (Igt, LLC Dba Eigen, 2012) has gone furthest, with 4 descendants of its own.
- 8 other devices also cite its predicate K081093.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · LLZ
58in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LLZ
173in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LLZ
11in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LLZ
116in 2025
MAUDE reports naming product code LLZ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 76 | 36 | 20 | 152 |
| 2008 | 94 | 52 | 32 | 154 |
| 2009 | 70 | 62 | 21 | 145 |
| 2010 | 51 | 98 | 17 | 145 |
| 2011 | 106 | 79 | 30 | 454 |
| 2012 | 82 | 87 | 12 | 266 |
| 2013 | 95 | 84 | 64 | 1,130 |
| 2014 | 78 | 89 | 6 | 15,631 |
| 2015 | 64 | 90 | 16 | 211 |
| 2016 | 82 | 90 | 12 | 290 |
| 2017 | 78 | 107 | 5 | 104 |
| 2018 | 104 | 105 | 7 | 72 |
| 2019 | 74 | 107 | 2 | 88 |
| 2020 | 81 | 115 | 6 | 82 |
| 2021 | 83 | 116 | 3 | 70 |
| 2022 | 65 | 137 | 4 | 28 |
| 2023 | 87 | 157 | 8 | 26 |
| 2024 | 62 | 131 | 6 | 42 |
| 2025 | 58 | 173 | 11 | 116 |
| 2026 | 45 | 110 | 14 | — |
What is it indicated for?
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…
Read the full statement (188 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093672 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093672: Aegis Navigation Anda Egis Pelvic Application.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093672
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026