510(k) Report

510(k) · Cleared

Cleared

DynaCAD

K192200510(k) TraditionalCleared Oct 9, 201957-day reviewClass II21 CFR 892.2050

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Invivo Corporation · LLZ System, Image Processing, Radiological

Cleared on Oct 9, 2019 as substantially equivalent to K121517 (Icad, Inc., 2012) after a 57-day review. Its family tree reaches back 1 generation to 2012. 6 later devices descend from it.

Decided
Oct 9, 2019
Review
57 days
Class
Class II
Product code
LLZ
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K121517 (2012). 6 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2020: 2 descendants cleared2021: 1 descendant cleared2024: 1 descendant cleared2022: 1 descendant cleared2023: 1 descendant clearedReference device: K133030 · Dynacad/Prostate Interventional (Dynaloc/Prostate) · Invivo Corporation · 2014 · recalledReference device: K090223 · Icad Breast Interventional Planning Software, Model D70024 · Icad, Inc. · 2009 · recalledK121517 · Versavue Enterprise Suite · Icad, Inc. · 2012 · recalled2010201520202025
Descendants, by generation 1 generation forward: 3 descendants2 generations forward: 2 descendants3 generations forward: 1 descendant K121517 · Versavue Enterprise Suite · Icad, Inc. · 2012 · recalled0
  1. Root · 1 generation backK121517 Versavue Enterprise SuiteIcad, Inc. · 2012 · Recalled
  2. This deviceK192200 DynaCADInvivo Corporation · 2019
  3. Descendant · cites it directly · 3 of its ownK202501 Quantib ProstateQuantib B.V. · 2020
  4. Descendant · 2 generations on · 1 of its ownK221106 Quantib ProstateQuantib B.V. · 2022
  5. Descendant · 2 generations on · 0 of its ownK233196 Medihub ProstateJLK, Inc. · 2024
  6. Descendant · 3 generations on · 0 of its ownK230772 Quantib ProstateQuantib B.V. · 2023
  7. Descendant · cites it directly · 0 of its ownK212175 DynaCADInvivo Corporation · 2021

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2020: 22021: 12022: 12023: 12024: 1
2020high 2 (2020) · low 0 (2025)2026

Most influential descendants

Showing 5 of 6 · See all
  • K202501Quantib ProstateQuantib B.V. · 2020 · cites it directly3descendants
  • K221106Quantib ProstateQuantib B.V. · 2022 · 2 generations on1descendant
  • K233196Medihub ProstateJLK, Inc. · 2024 · 2 generations on0descendants
  • K230772Quantib ProstateQuantib B.V. · 2023 · 3 generations on0descendants
  • K212175DynaCADInvivo Corporation · 2021 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K121517Versavue Enterprise SuiteIcad, Inc.20121
0 (this device)K192200DynaCADInvivo Corporation2019—
+1K202501Quantib ProstateQuantib B.V.2020—
+2K221106Quantib ProstateQuantib B.V.2022—
+2K233196Medihub ProstateJLK, Inc.2024—
+3K230772Quantib ProstateQuantib B.V.2023—
+1K212175DynaCADInvivo Corporation2021—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202020
202110
202210
202310
202410
FIG. 1 — Lineage of K192200, 2012–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K230955 syngo Application Softwarescore 21.5 · 11 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K121517Versavue Enterprise Suite
Summary page 5
…following devices: Predicate Device 510(k) VersaVue Enterprise Suite K121517 Reference Devices 510(k) DynaCAD/Prostate Interventional…
Icad, Inc.20121
†K133030Dynacad/Prostate Interventional (Dynaloc/Prostate)Invivo Corporation20141
†K090223Icad Breast Interventional Planning Software, Model D70024Icad, Inc.20091

Also cleared against K121517: 1 other device →

What descends from it? (6)

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K202501Quantib ProstateQuantib B.V.20203
K212175DynaCADInvivo Corporation20210
K193306PROViewGE Medical Systems SCS20200

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?

  • Its one ancestor has a recall.
  • Of its descendants, K202501 (Quantib B.V., 2020) has gone furthest, with 3 descendants of its own.
  • 1 other device also cites its predicate K121517.

How does its category compare?

All LLZ devices

LLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.

FDA decisions per year · LLZ

58in 2025

2007: 762008: 942009: 702010: 512011: 1062012: 822013: 952014: 782015: 642016: 822017: 782018: 1042019: 742020: 812021: 832022: 652023: 872024: 622025: 582026 (partial year): 45
2007high 106 (2011) · low 51 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LLZ

173in 2025

2007: 36 days median2008: 52 days median2009: 62 days median2010: 98 days median2011: 79 days median2012: 87 days median2013: 84 days median2014: 89 days median2015: 90 days median2016: 90 days median2017: 107 days median2018: 105 days median2019: 107 days median2020: 115 days median2021: 116 days median2022: 137 days median2023: 157 days median2024: 131 days median2025: 173 days median2026 (partial year): 110 days median
2007high 173 (2025) · low 36 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LLZ

11in 2025

2007: 202008: 322009: 212010: 172011: 302012: 122013: 642014: 62015: 162016: 122017: 52018: 72019: 22020: 62021: 32022: 42023: 82024: 62025: 112026 (partial year): 14
2007high 64 (2013) · low 2 (2019)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LLZ

116in 2025

2007: 1522008: 1542009: 1452010: 1452011: 4542012: 2662013: 1,1302014: 15,6312015: 2112016: 2902017: 1042018: 722019: 882020: 822021: 702022: 282023: 262024: 422025: 116
2007high 15,631 (2014) · low 26 (2023)2025

MAUDE reports naming product code LLZ, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007763620152
2008945232154
2009706221145
2010519817145
20111067930454
2012828712266
20139584641,130
20147889615,631
2015649016211
2016829012290
2017781075104
2018104105772
201974107288
202081115682
202183116370
202265137428
202387157826
202462131642
20255817311116
20264511014—

What is it indicated for?

DynaCAD The DynaCAD software consists of the MR Analysis Server software and the viewer workstation software. The MR Analysis Server software, which includes the DynaCAD Breast, DynaCAD Prostate, and DynaCAD PK for other MR Analysis modules, is intended to be used as a post-processing software package designed to provide a reliable means for analyzing MR datasets. The software facilitates the analysis of dynamic and non-dynamic MR datasets to provide…

Read the full statement (442 words)

DynaCAD

The DynaCAD software consists of the MR Analysis Server software and the viewer workstation software.

The MR Analysis Server software, which includes the DynaCAD Breast, DynaCAD Prostate, and DynaCAD PK for other MR Analysis modules, is intended to be used as a post-processing software package designed to provide a reliable means for analyzing MR datasets. The software facilitates the analysis of dynamic and non-dynamic MR datasets to provide study review and additional mathematical and/or statistical analysis. The resulting analysis can be displayed in a variety of formats, including parametric images overlaid onto source MRI images.

The viewer workstation software is intended for use in conjunction with the MR Analysis Server software and facilitates the analysis and presentation of datasets generated by the MR Analysis Server software and incorporates the following functions: Region of Interest (ROI) curve, Pixel of Interest (POI) curve, Report Card, Volume Calculation, Statistical Analysis, 3-D visualization of image series, and DICOM reporting, among other capabilities.

DynaCAD software serves as a workflow roadmap tool that organizes and guides the radiologist through the series of sequential tasks that must be performed in order to arrive at a diagnosis. The specific configuration of product features drives the DynaCAD software underlying workflow solution for lesion characterization and reporting. This inherent workflow regimen integrates into the radiologist‘s existing departmental workflow and can be adapted to fit the needs of each user. In the hands of a trained physician the information provided by the data analysis could yield information that may assist in the interpretation of dynamic and non-dynamic MR studies.

DynaLOC Breast

The DynaLOC Breast Interventional Planning software module supports the use of interventional breast coils and MR stereotactic localization devices to perform 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.

DynaLOC Prostate

DynaLOC 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.

Cite this page

510(k) Report. “K192200: DynaCAD.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192200

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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