510(k) Report

510(k) · Cleared

Cleared

Intuition - Tda, Tva, Parametric Mapping

K131447510(k) TraditionalCleared Dec 24, 2013218-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

Terarecon,Inc. · LLZ System, Image Processing, Radiological

Cleared on Dec 24, 2013 as substantially equivalent to K011142 (Terarecon,Inc., 2001) and 6 other predicates after a 218-day review. Its family tree reaches back 10 generations to 1997. 2 of the 81 devices in its family, counting itself, have a Class I recall. 2 later devices descend from it.

Decided
Dec 24, 2013
Review
218 days
Class
Class II
Product code
LLZ
Recalls
None
Predicates
7

Its longest line of descent runs back 10 generations to K971684 (1997). 78 ancestors in all, the oldest K913770 (1991). 2 later devices descend from it, 1 citing it directly. 2 of the 81 devices in this family, counting this one, have a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 2011: 2 other ancestors2006: 5 other ancestors2004: 6 other ancestors2001: 12 other ancestors2009: 2 other ancestors2008: 4 other ancestors2007: 3 other ancestors2002: 3 other ancestors2010: 1 other ancestor2005: 4 other ancestors2003: 4 other ancestors2000: 5 other ancestors1999: 3 other ancestors1998: 2 other ancestors1997: 4 other ancestors1996: 3 other ancestors1994: 2 other ancestors1995: 2 other ancestors1991: 1 other ancestor2020: 1 descendant cleared2022: 1 descendant clearedK971684 · Magnetom Project 047 System (Numaris 3.5 Software) · Siemens Medical Solutions USA, Inc. · 1997 · recalledK032428 · Magnetom Avanto MR System · Siemens Medical Solutions USA, Inc. · 2003 · recalledK041112 · Magnetom Espree System · Siemens Medical Solutions USA, Inc. · 2004 · recalledK052164 · Magnetom Systems with Software Syngo MR 2006A · Siemens Medical Solutions USA, Inc. · 2005K062454 · Magnetom Systems - I-Class and T-Class Releases · Siemens Medi Cal Solutions, Inc. · 2006K072237 · Magnetom Verio · Siemens Medical Solutions USA, Inc. · 2007 · Class I recallK082427 · Syngo MR B17 · Siemens Medical Solutions USA, Inc. · 2008K101347 · Magnetom Aera; Magnetom Skyra · Siemens Medical Solutions USA, Inc. · 2010 · Class I recallK111242 · Magnetom Aera and Magnetom Skyra · Siemens Medical Solutions USA, Inc. · 2011 · recalledK121459 · Syngo.MR Neurology · Siemens Medical Solutions USA, Inc. · 20121990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 6 other ancestors2 generations back: 10 other ancestors3 generations back: 17 other ancestors4 generations back: 14 other ancestors5 generations back: 17 other ancestors6 generations back: 4 other ancestors 1 generation forward: 1 descendant2 generations forward: 1 descendant K121459 · Syngo.MR Neurology · Siemens Medical Solutions USA, Inc. · 2012K111242 · Magnetom Aera and Magnetom Skyra · Siemens Medical Solutions USA, Inc. · 2011 · recalledK101347 · Magnetom Aera; Magnetom Skyra · Siemens Medical Solutions USA, Inc. · 2010 · Class I recallK082427 · Syngo MR B17 · Siemens Medical Solutions USA, Inc. · 2008K072237 · Magnetom Verio · Siemens Medical Solutions USA, Inc. · 2007 · Class I recallK062454 · Magnetom Systems - I-Class and T-Class Releases · Siemens Medi Cal Solutions, Inc. · 2006K052164 · Magnetom Systems with Software Syngo MR 2006A · Siemens Medical Solutions USA, Inc. · 2005K041112 · Magnetom Espree System · Siemens Medical Solutions USA, Inc. · 2004 · recalledK032428 · Magnetom Avanto MR System · Siemens Medical Solutions USA, Inc. · 2003 · recalledK971684 · Magnetom Project 047 System (Numaris 3.5 Software) · Siemens Medical Solutions USA, Inc. · 1997 · recalled−10−50
  1. Root · 10 generations backK971684 Magnetom Project 047 System (Numaris 3.5 Software)Siemens Medical Solutions USA, Inc. · 1997 · Recalled
  2. 6 generations between
  3. 3 generations backK101347 Magnetom Aera; Magnetom SkyraSiemens Medical Solutions USA, Inc. · 2010 · Recalled (Class I)
  4. 2 generations backK111242 Magnetom Aera and Magnetom SkyraSiemens Medical Solutions USA, Inc. · 2011 · Recalled
  5. 1 generation backK121459 Syngo.MR NeurologySiemens Medical Solutions USA, Inc. · 2012
  6. This deviceK131447 Intuition - Tda, Tva, Parametric MappingTerarecon,Inc. · 2013
  7. Descendant · cites it directly · 1 of its ownK200750 Neuro.Al AlgorithmTerarecon,Inc. · 2020
  8. Descendant · 2 generations on · 0 of its ownK220349 TeraRecon NeuroTerarecon,Inc. · 2022
Show all 10 generations
  1. Root · 10 generations backK971684 Magnetom Project 047 System (Numaris 3.5 Software)Siemens Medical Solutions USA, Inc. · 1997 · Recalled
  2. 9 generations backK032428 Magnetom Avanto MR SystemSiemens Medical Solutions USA, Inc. · 2003 · Recalled
  3. 8 generations backK041112 Magnetom Espree SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
  4. 7 generations backK052164 Magnetom Systems with Software Syngo MR 2006ASiemens Medical Solutions USA, Inc. · 2005
  5. 6 generations backK062454 Magnetom Systems - I-Class and T-Class ReleasesSiemens Medi Cal Solutions, Inc. · 2006
  6. 5 generations backK072237 Magnetom VerioSiemens Medical Solutions USA, Inc. · 2007 · Recalled (Class I)
  7. 4 generations backK082427 Syngo MR B17Siemens Medical Solutions USA, Inc. · 2008
  8. 3 generations backK101347 Magnetom Aera; Magnetom SkyraSiemens Medical Solutions USA, Inc. · 2010 · Recalled (Class I)
  9. 2 generations backK111242 Magnetom Aera and Magnetom SkyraSiemens Medical Solutions USA, Inc. · 2011 · Recalled
  10. 1 generation backK121459 Syngo.MR NeurologySiemens Medical Solutions USA, Inc. · 2012
  11. This deviceK131447 Intuition - Tda, Tva, Parametric MappingTerarecon,Inc. · 2013

Class I recalls in this family

  • K101347 Magnetom Aera; Magnetom Skyra3 generations back · 2010
  • K072237 Magnetom Verio3 generations back · 2007

Most influential descendants

Showing 2 of 2 · See all
  • K200750Neuro.Al AlgorithmTerarecon,Inc. · 2020 · cites it directly1descendant
  • K220349TeraRecon NeuroTerarecon,Inc. · 2022 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−10K971684Magnetom Project 047 System (Numaris 3.5 Software)Siemens Medical Solutions USA, Inc.19974
−9K032428Magnetom Avanto MR SystemSiemens Medical Solutions USA, Inc.20034
−8K041112Magnetom Espree SystemSiemens Medical Solutions USA, Inc.20044
−7K052164Magnetom Systems with Software Syngo MR 2006ASiemens Medical Solutions USA, Inc.2005—
−6K062454Magnetom Systems - I-Class and T-Class ReleasesSiemens Medi Cal Solutions, Inc.2006—
−5K072237Magnetom VerioSiemens Medical Solutions USA, Inc.2007Class I
−4K082427Syngo MR B17Siemens Medical Solutions USA, Inc.2008—
−3K101347Magnetom Aera; Magnetom SkyraSiemens Medical Solutions USA, Inc.2010Class I
−2K111242Magnetom Aera and Magnetom SkyraSiemens Medical Solutions USA, Inc.20113
−1K121459Syngo.MR NeurologySiemens Medical Solutions USA, Inc.2012—
0 (this device)K131447Intuition - Tda, Tva, Parametric MappingTerarecon,Inc.2013—
+1K200750Neuro.Al AlgorithmTerarecon,Inc.2020—
+2K220349TeraRecon NeuroTerarecon,Inc.2022—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199110
199420
199520
199630
199740
199820
199930
200050
2001120
200230
200340
200460
200540
200650
200730
200840
200920
201010
201120

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202010
202210
FIG. 1 — Lineage of K131447, 1997–2022Source: 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.

2 devices in this family have a Class I recall. 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? (7)

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
*K011142Aquarius WorkstationTerarecon,Inc.2001—
*K061214Aquariusaps Server
Summary page 1
…, is substantially equivalent to the following commercially, available devices: * Aquarius Workstation (KOI 11142) * AquariusAPS Server (K(061214) *LEONARDO syngo Cardiology Workstation (Argus) (K(042203) *LEONARDO (K040970) *Syng…
Terarecon,Inc.2006—
*K042203Leonardo Syngo Cardiology Workstation
Summary page 1
…vices: * Aquarius Workstation (KOI 11142) * AquariusAPS Server (K(061214) *LEONARDO syngo Cardiology Workstation (Argus) (K(042203) *LEONARDO (K040970) *Syngo~CT Cardiac Function (K 110366) *CT Perfusion 4 (K(052839…
Siemens Medical Solutions USA, Inc.2004—
*K040970Leonardo
Summary page 1
…Workstation (KOI 11142) * AquariusAPS Server (K(061214) *LEONARDO syngo Cardiology Workstation (Argus) (K(042203) *LEONARDO (K040970) *Syngo~CT Cardiac Function (K 110366) *CT Perfusion 4 (K(052839) *Syngo.MR Neurolog…
Siemens Medical Systems, Inc.20041
*K110366Syngo.CT Cardiac Function
Summary page 1
…Server (K(061214) *LEONARDO syngo Cardiology Workstation (Argus) (K(042203) *LEONARDO (K040970) *Syngo~CT Cardiac Function (K 110366) *CT Perfusion 4 (K(052839) *Syngo.MR Neurology (K 121459) iNtuition TDA has similar technological…
Siemens AG20111
*K052839CT Perfusion 4
Summary page 1
…syngo Cardiology Workstation (Argus) (K(042203) *LEONARDO (K040970) *Syngo~CT Cardiac Function (K 110366) *CT Perfusion 4 (K(052839) *Syngo.MR Neurology (K 121459) iNtuition TDA has similar technological characteristics to the Aquarius Workstati…
GE Healthcare20061
*K121459Syngo.MR Neurology
Summary page 1
…03) *LEONARDO (K040970) *Syngo~CT Cardiac Function (K 110366) *CT Perfusion 4 (K(052839) *Syngo.MR Neurology (K 121459) iNtuition TDA has similar technological characteristics to the Aquarius Workstation, AquariusAPS Server and CT Perf'usion 4, wi…
Siemens Medical Solutions USA, Inc.2012—

Also cleared against K011142: 7 other devices →

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K200750Neuro.Al AlgorithmTerarecon,Inc.20201

Has anything in its family been recalled? (2 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K101347Magnetom Aera; Magnetom SkyraSiemens Medical Solutions USA, Inc. · 2010 · 3 generations back · ◆ on the line of descent in FIG. 12 Class I recalls
  • K072237Magnetom VerioSiemens Medical Solutions USA, Inc. · 2007 · 3 generations back · ◆ on the line of descent in FIG. 11 Class I recall

What does this lineage say?

  • The line of descent spans 16 years and passes through 3 companies; a new generation was cleared every 1.1 years on median.
  • 23 of the 78 ancestors have a recall of any class; 2 have a Class I recall.
  • Of its descendants, K200750 (Terarecon,Inc., 2020) has gone furthest, with 1 descendant of its own.
  • 7 other devices also cite its predicate K011142.

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. 2013, 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?

iNtuition-TDA, TVA, and Parametric Mapping are software modules which supports assessment of time-dependent behavior of image intensity, density, dimensions or volume of regions of interest over time, for volumetric or planar dynamic image types such as CT or MR. Parametric mapping tools encode in color various parameters derived from the temporal or spatial characteristics of the planar or volumetric data. Support is provided for digital image…

Read the full statement (184 words)

iNtuition-TDA, TVA, and Parametric Mapping are software modules which supports assessment of time-dependent behavior of image intensity, density, dimensions or volume of regions of interest over time, for volumetric or planar dynamic image types such as CT or MR. Parametric mapping tools encode in color various parameters derived from the temporal or spatial characteristics of the planar or volumetric data.

Support is provided for digital image processing to derive metadata or new images from input image sets, for internal use or for forwarding to other devices using the DICOM protocol. Image processing tools are provided to extract metadata to derive Parametric images from combinations of multiple input images.

iNtuition-TDA, TVA and Parametric Mapping are iNtution based software features with dedicated workflows and basic tools and thus support post-processing, displaying and manipulation of reports and medical images from acquisition devices and visualization in 2D, 3D and 4D for single or multiple datasets, or combinations thereof.

iNtuition-TDA, TVA, Paramietric Mapping are designed for use by healthcare professionals and are intended to assist the physician in diagnosis, who is responsible for making all final patient management decisions.

Indications for use as stated in the FDA summary.

Also cleared against K011142

7 other devices cite the same predicate.

  • K121916IntuitionTerarecon,Inc. · 20131 recall
  • K120734Microsoft Amalga Uis Image Processing ModuleMicrosoft Corp. · 2012
  • K103720Synapse 3D Lung and Abdomen AnalysisFujifilm Medical Systems U.S.A, Inc. · 2011
  • K083691BonevueMicromri, Inc. · 2009
  • K082269Visage Pacs, Version 6.0/CS 3.1Visage Imaging, Inc. · 2008
  • K051809Easyviz, Easyviz System, Easyviz Pacs System, Easyviz Image and Data Management SystemMedical Insight A/S · 2005

More from Terarecon,Inc.

14 FDA decisions under this applicant name. See the company

  • K250288TeraRecon Cardiovascular.Calcification.CTTerarecon,Inc. · 2025
  • K243158TeraRecon Aorta.CT (1.1.0)Terarecon,Inc. · 2025
  • K241312TeraRecon Cardiac.Chambers.MR (1.0.0)Terarecon,Inc. · 2024
  • K220349TeraRecon NeuroTerarecon,Inc. · 2022
  • K200750Neuro.Al AlgorithmTerarecon,Inc. · 2020

Recent decisions in LLZ

The LLZ category page

  • K261788Eden PACSHigia., Inc. d/b/a Eden · 2026
  • K261531PV-iCurve ProPerception Vision Medical Technology Co., Ltd. · 2026
  • K263048Syngo Carbon Space (VA4)Siemens Healthineers AG · 2026
  • K261874Syneris PACS v.1.0.1.0Syneris · 2026
  • K262442HipStudio AnalysisReplasia BV · 2026

https://510kreport.com/device/K131447 · printed Nov 6, 2026

Cite this page

510(k) Report. “K131447: Intuition - Tda, Tva, Parametric Mapping.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131447

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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