510(k) · Cleared
Recalled · Class II · 2015Icad Breast Interventional Planning Software, Model D70024
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Icad, Inc. · LLZ System, Image Processing, Radiological
Cleared on Mar 31, 2009 as substantially equivalent to K043216 (Confirma, Inc., 2005) and 2 other predicates after a 60-day review. Its family tree reaches back 6 generations to 1996. It has been recalled once.
- Decided
- Mar 31, 2009
- Review
- 60 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 6 generations to K954678 (1996). 34 ancestors in all, the oldest K913475 (1991). No later device cites it as a predicate yet.
- Root · 6 generations backK954678 Pro VisionAlgotec Systems, Ltd. · 1996
- 5 generations backK980648 Pro VisionAlgotec Systems, Ltd. · 1998
- 4 generations backK992654 Plug 'N View 3D, Version 1.0Voxar Limited · 1999
- 3 generations backK020546 Fusion 7DMirada Solutions, Ltd. · 2002
- 2 generations backK031779 CadstreamConfirma, Inc. · 2003
- 1 generation backK041286 Dynacad V1.0Mri Devices Corp. · 2004
- This deviceK090223 Icad Breast Interventional Planning Software, Model D70024Icad, Inc. · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K954678 | Pro Vision | Algotec Systems, Ltd. | 1996 | — |
| −5 | K980648 | Pro Vision | Algotec Systems, Ltd. | 1998 | — |
| −4 | K992654 | Plug 'N View 3D, Version 1.0 | Voxar Limited | 1999 | — |
| −3 | K020546 | Fusion 7D | Mirada Solutions, Ltd. | 2002 | — |
| −2 | K031779 | Cadstream | Confirma, Inc. | 2003 | — |
| −1 | K041286 | Dynacad V1.0 | Mri Devices Corp. | 2004 | — |
| 0 (this device) | K090223 | Icad Breast Interventional Planning Software, Model D70024 | Icad, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 2 | 0 |
| 1994 | 3 | 0 |
| 1995 | 2 | 0 |
| 1996 | 3 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 4 | 0 |
| 2002 | 3 | 0 |
| 2003 | 4 | 0 |
| 2004 | 1 | 0 |
| 2005 | 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.
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 21.5 · 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 |
|---|---|---|---|
| * | K043216 | Cadstream Version 4.0Summary page 2…Reference Device Name Software Module Used For Manufacturer No. Interventional Planning K043216 CADstreamTM Version 4.0 SureLOC TM Confirma, Inc. K041286 DynaCAD Tm V… | 2005 |
| * | K041286 | Dynacad V1.0Summary page 2…Interventional Planning K043216 CADstreamTM Version 4.0 SureLOC TM Confirma, Inc. K041286 DynaCAD Tm V1.0 DynaLOC Tm MRI Devices… | 2004 |
| * | K020289 | Mics Intervention Aid, Catalog # Mics-Mia and Mics-MiasSummary page 2…AD Tm V1.0 DynaLOC Tm MRI Devices Corporation K020289 MICS Intervention Aid MICS-MIAS Machnet BV DEVICE DESCRIPTION The iCAD Breast In… | 2002 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 21, 2015 | Class II | Z-1243-2015 | Device Design | A device malfunction may cause the biopsy needle to fail to reach the intended target. If location confirming radiographs are not taken and properly evaluated, biopsy site mislocation can result in non-target tissue being sampled rather… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 6 companies; a new generation was cleared every 2.5 years on median.
- 8 of the 34 ancestors have a recall of any class.
- 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. 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?
The iCAD Breast Interventional Planning Software supports the use of interventional breast coils and MR stereotactic localization devices to perform magnetic resonance (MR) guided breast interventional procedures. Using information from MR images regarding the coordinates of a user-specified region of interest, and fiducial coordinates, the software provides an automatic calculation of the location and depth of the targeted region of interest, such as a lesion or suspected lesion relative to the interventional device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090223 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090223: Icad Breast Interventional Planning Software, Model D70024.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090223
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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