510(k) · Cleared
ClearedProBx Software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Harmonus, Inc. · LLZ System, Image Processing, Radiological
Cleared on Mar 2, 2018 as substantially equivalent to K133030 (Invivo Corporation, 2014) after a 134-day review. Its family tree reaches back 7 generations to 1996.
- Decided
- Mar 2, 2018
- Review
- 134 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K954678 (1996). 25 ancestors in all, the oldest K913475 (1991). No later device cites it as a predicate yet.
- Root · 7 generations backK954678 Pro VisionAlgotec Systems, Ltd. · 1996
- 6 generations backK980648 Pro VisionAlgotec Systems, Ltd. · 1998
- 5 generations backK992654 Plug 'N View 3D, Version 1.0Voxar Limited · 1999
- 4 generations backK020546 Fusion 7DMirada Solutions, Ltd. · 2002
- 3 generations backK031779 CadstreamConfirma, Inc. · 2003
- 2 generations backK041286 Dynacad V1.0Mri Devices Corp. · 2004
- 1 generation backK133030 Dynacad/Prostate Interventional (Dynaloc/Prostate)Invivo Corporation · 2014 · Recalled
- This deviceK173312 ProBx SoftwareHarmonus, Inc. · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K954678 | Pro Vision | Algotec Systems, Ltd. | 1996 | — |
| −6 | K980648 | Pro Vision | Algotec Systems, Ltd. | 1998 | — |
| −5 | K992654 | Plug 'N View 3D, Version 1.0 | Voxar Limited | 1999 | — |
| −4 | K020546 | Fusion 7D | Mirada Solutions, Ltd. | 2002 | — |
| −3 | K031779 | Cadstream | Confirma, Inc. | 2003 | — |
| −2 | K041286 | Dynacad V1.0 | Mri Devices Corp. | 2004 | — |
| −1 | K133030 | Dynacad/Prostate Interventional (Dynaloc/Prostate) | Invivo Corporation | 2014 | 1 |
| 0 (this device) | K173312 | ProBx Software | Harmonus, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 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 |
|---|---|---|---|
| * | K133030 | Dynacad/Prostate Interventional (Dynaloc/Prostate)Summary page 5…Image Processing, Radiological, LLZ Classification regulation: 21 CFR 892.2050, Product Code LLZ Predicate Device: DynaCAD/Prostate Interventional, K133030 Device Description: ProBx Software along with ProBx Hardware accessories is used for in-bore Magnetic Resonance Imaging (MRI) gu… | 2014 |
| † | K170250 | SmartTarget | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
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 22 years and passes through 7 companies; a new generation was cleared every 2.5 years on median.
- 6 of the 25 ancestors have a recall of any class.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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?
ProBx Software is intended for use as follows: • ProBx Software is a computer-based image-guidance accessory intended for use in conjunction with commercially available Magnetic Resonance Imaging (MRI) systems and interventional devices. • ProBx Software helps physicians guide biopsy instrumentation to targets that have been defined by the physician in MRI. The Software provides the clinician with image analysis and display of pre-procedural and…
Read the full statement (128 words)
ProBx Software is intended for use as follows:
• ProBx Software is a computer-based image-guidance accessory intended for use in conjunction with commercially available Magnetic Resonance Imaging (MRI) systems and interventional devices.
• ProBx Software helps physicians guide biopsy instrumentation to targets that have been defined by the physician in MRI. The Software provides the clinician with image analysis and display of pre-procedural and intra-procedural MRI images of tracked accessory hardware and the target organs, along with the projected path to the target. The Software displays an MRI image of the current location of the interventional instrument for positioning confirmation.
• ProBx Software is intended to be used by physicians in a clinical setting for treatment planning and guidance for clinical, interventional, and/or diagnostic procedures of the prostate.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173312 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173312: ProBx Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173312
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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