510(k) · Cleared
Recalled · Class II · 2018Dynacad/Prostate Interventional (Dynaloc/Prostate)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Invivo Corporation · LLZ System, Image Processing, Radiological
Cleared on Jan 22, 2014 as substantially equivalent to K041286 (Mri Devices Corp., 2004) after a 118-day review. Its family tree reaches back 6 generations to 1996. 1 later device descends from it. It has been recalled once.
- Decided
- Jan 22, 2014
- Review
- 118 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 6 generations to K954678 (1996). 24 ancestors in all, the oldest K913475 (1991). 1 later device descends from it, 1 citing it directly.
- 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 deviceK133030 Dynacad/Prostate Interventional (Dynaloc/Prostate)Invivo Corporation · 2014
- Descendant · cites it directly · 0 of its ownK173312 ProBx SoftwareHarmonus, Inc. · 2018
Most influential descendants
Showing 1 of 1 · See all- K173312ProBx SoftwareHarmonus, Inc. · 2018 · cites it directly0descendants
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) | K133030 | Dynacad/Prostate Interventional (Dynaloc/Prostate) | Invivo Corporation | 2014 | — |
| +1 | 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 |
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.
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 |
|---|---|---|---|
| K173312 | ProBx Software | 2018 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 24, 2018 | Class II | Z-1289-2018 | Other | Following update from 3.3 to 3.5 of the DynaCAD software it was noted that the Ktrans map was not rendered correctly on the DynaCad Client. The defect causes the pharmacokinetic (PK) color maps to display incorrectly when viewed from… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 18 years and passes through 6 companies; a new generation was cleared every 2.5 years on median.
- 5 of the 24 ancestors have a recall of any class.
- Of its descendants, K173312 (Harmonus, Inc., 2018) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K041286.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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?
DynaCAD/Prostate Interventional is a computer-based image-guidance accessory for use with commercially available Magnetic Resonance (MR) imaging systems and interventional devices. The application provides the user with patient data processing, visualization and storage functions. It allows image analysis, display and recording of simulated images of a tracked insertion tool, such as a needle guide or sleeve, on a computer monitor or other display that…
Read the full statement (106 words)
DynaCAD/Prostate Interventional is a computer-based image-guidance accessory for use with commercially available Magnetic Resonance (MR) imaging systems and interventional devices.
The application provides the user with patient data processing, visualization and storage functions. It allows image analysis, display and recording of simulated images of a tracked insertion tool, such as a needle guide or sleeve, on a computer monitor or other display that shows images of the target organs and the current and/or projected path of the interventional instrument.
The device 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/K133030 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133030: Dynacad/Prostate Interventional (Dynaloc/Prostate).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133030
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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