510(k) · Cleared
ClearedAEGIS
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 Feb 9, 2007 as substantially equivalent to K043216 (Confirma, Inc., 2005) after a 15-day review. Its family tree reaches back 5 generations to 1991. 89 later devices descend from it.
- Decided
- Feb 9, 2007
- Review
- 15 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K913770 (1991). 8 ancestors in all. 89 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 4 generations backK960613 GE Advantage Windows Review WorkstationGE Medical Systems · 1996
- 3 generations backK020483 Advantage Workstation 4.1GE Medical Systems · 2002 · Recalled
- 2 generations backK033400 Seno AdvantageGe Medical Systems W-400 · 2003 · Recalled
- 1 generation backK043216 Cadstream Version 4.0Confirma, Inc. · 2005
- This deviceK070244 AEGISSentinelle Medical, Inc. · 2007
- Descendant · cites it directly · 79 of its ownK093462 Sonix Ultrasound ScannerUltrasonix Medical Corporation · 2009
- Descendant · 2 generations on · 77 of its ownK102997 Sonixtablet Ultrasound ScannerUltrasonix Medical Corporation · 2010
- Descendant · 3 generations on · 75 of its ownK113663 Sonixtablet Ultrasound ScannerUltrasonix Medical Corporation · 2012
- Descendant · 3 generations on · 74 of its ownK123001 Acuson X700 Diagnstic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2012 · Recalled
- Descendant · 4 generations on · 73 of its ownK132804 Acuson S1000 / S2000 / S3000Siemens Medical Solutions USA, Inc. Ultrasound Gro · 2013 · Recalled
Showing 5 of 89 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 89 · See all- K093462Sonix Ultrasound ScannerUltrasonix Medical Corporation · 2009 · cites it directly79descendants
- K102997Sonixtablet Ultrasound ScannerUltrasonix Medical Corporation · 2010 · 2 generations on77descendants
- K113663Sonixtablet Ultrasound ScannerUltrasonix Medical Corporation · 2012 · 3 generations on75descendants
- K123001Acuson X700 Diagnstic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2012 · 3 generations on74descendants
- K132804Acuson S1000 / S2000 / S3000Siemens Medical Solutions USA, Inc. Ultrasound Gro · 2013 · 4 generations on73descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −4 | K960613 | GE Advantage Windows Review Workstation | GE Medical Systems | 1996 | — |
| −3 | K020483 | Advantage Workstation 4.1 | GE Medical Systems | 2002 | 2 |
| −2 | K033400 | Seno Advantage | Ge Medical Systems W-400 | 2003 | 6 |
| −1 | K043216 | Cadstream Version 4.0 | Confirma, Inc. | 2005 | — |
| 0 (this device) | K070244 | AEGIS | Sentinelle Medical, Inc. | 2007 | — |
| +1 | K093462 | Sonix Ultrasound Scanner | Ultrasonix Medical Corporation | 2009 | — |
| +2 | K102997 | Sonixtablet Ultrasound Scanner | Ultrasonix Medical Corporation | 2010 | — |
| +3 | K113663 | Sonixtablet Ultrasound Scanner | Ultrasonix Medical Corporation | 2012 | — |
| +3 | K123001 | Acuson X700 Diagnstic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2012 | 2 |
| +4 | K132804 | Acuson S1000 / S2000 / S3000 | Siemens Medical Solutions USA, Inc. Ultrasound Gro | 2013 | 3 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 2 | 0 |
| 2014 | 6 | 0 |
| 2015 | 3 | 0 |
| 2016 | 5 | 0 |
| 2017 | 7 | 0 |
| 2018 | 5 | 0 |
| 2019 | 5 | 0 |
| 2020 | 7 | 0 |
| 2021 | 9 | 0 |
| 2022 | 8 | 0 |
| 2023 | 7 | 0 |
| 2024 | 7 | 0 |
| 2025 | 7 | 0 |
| 2026 | 4 | 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.
Planning a device in LLZ? 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 21.6 · 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? (1)
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 |
|---|---|---|---|
| * | K043216 | Cadstream Version 4.0Summary page 1…d Device: Predicate Device: CADStream Th Version 4.0 Predicate Device Manufacturer: Confirma, Inc. Predicate Device 510(k) Number: K043216 Date Received: 11/19/2004 Decision Date: 11/22/2004 Decision:… | 2005 |
What descends from it? (89)
See all 892 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 5 companies; a new generation was cleared every 2.1 years on median.
- 2 of the 8 ancestors have a recall of any class.
- Of its descendants, K093462 (Ultrasonix Medical Corporation, 2009) has gone furthest, with 79 descendants of its own.
- 8 other devices also cite its predicate K043216.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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?
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…
Read the full statement (249 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070244 · printed Nov 3, 2026
Cite this page
510(k) Report. “K070244: AEGIS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K070244
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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