510(k) · Cleared
ClearedFusion Bx
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Focal Healtcare, Inc. · LLZ System, Image Processing, Radiological
Cleared on Jan 25, 2016 as substantially equivalent to K081093 (Eigen, LLC, 2008) after an 84-day review. Its family tree reaches back 5 generations to 1996. 1 later device descends from it.
- Decided
- Jan 25, 2016
- Review
- 84 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K954678 (1996). 10 ancestors in all, the oldest K953259 (1995). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK954678 Pro VisionAlgotec Systems, Ltd. · 1996
- 4 generations backK980648 Pro VisionAlgotec Systems, Ltd. · 1998
- 3 generations backK992654 Plug 'N View 3D, Version 1.0Voxar Limited · 1999
- 2 generations backK063107 3DNET SuiteBiotronics3D, Ltd. · 2006
- 1 generation backK081093 3-D Imaging WorkstationEigen, LLC · 2008
- This deviceK153166 Fusion BxFocal Healtcare, Inc. · 2016
- Descendant · cites it directly · 0 of its ownK181290 Fusion Bx 2.0Focal Healthcare, Inc. · 2018
Most influential descendants
Showing 1 of 1 · See all- K181290Fusion Bx 2.0Focal Healthcare, Inc. · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K954678 | Pro Vision | Algotec Systems, Ltd. | 1996 | — |
| −4 | K980648 | Pro Vision | Algotec Systems, Ltd. | 1998 | — |
| −3 | K992654 | Plug 'N View 3D, Version 1.0 | Voxar Limited | 1999 | — |
| −2 | K063107 | 3DNET Suite | Biotronics3D, Ltd. | 2006 | — |
| −1 | K081093 | 3-D Imaging Workstation | Eigen, LLC | 2008 | — |
| 0 (this device) | K153166 | Fusion Bx | Focal Healtcare, Inc. | 2016 | — |
| +1 | K181290 | Fusion Bx 2.0 | Focal Healthcare, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 2000 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 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? (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 |
|---|---|---|---|
| * | K081093 | 3-D Imaging WorkstationSummary page 6…opsies were acquired during the procedure. Substantial Equivalence The product’s technical features are substantially equivalent to the Eigen 3-D imaging Workstation (K081093). Both are software applications that provide 2D and 3D medical image viewing and acquisition to aid visualization of the prostat… | 2008 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K181290 | Fusion Bx 2.0 | 2018 | 0 |
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 20 years and passes through 5 companies; a new generation was cleared every 2.5 years on median.
- 2 of the 10 ancestors have a recall of any class.
- Of its descendants, K181290 (Focal Healthcare, Inc., 2018) has gone furthest, with 0 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. 2016, 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?
Fusion Bx is intended for use by physicians for enhanced visualization of ultrasound imaging of the prostate in clinic and hospital settings. It provides 2D and 3D image visualization including review, manipulation, and analysis tools. Additional features include patient data management, image measurement, multiplanar reconstruction, 3D image registration, segmentation, image annotation, and to record the locations where the biopsies were acquired during the procedure.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K153166 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153166: Fusion Bx.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153166
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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