510(k) Report

510(k) · Cleared

Recalled · 2009

Iluma Vision

K081347510(k) TraditionalCleared May 28, 200814-day reviewClass II21 CFR 892.2050Recalls 1

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

Imtec Corp. · LLZ System, Image Processing, Radiological

Cleared on May 28, 2008 after a 14-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 26 later devices descend from it. It has been recalled once.

Decided
May 28, 2008
Review
14 days
Class
Class II
Product code
LLZ
Recalls
1
Predicates
0

26 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2013: 1 descendant cleared2010: 1 descendant cleared2014: 3 descendants cleared2017: 2 descendants cleared2018: 3 descendants cleared2020: 3 descendants cleared2025: 3 descendants cleared2026: 6 descendants cleared2019: 1 descendant cleared2022: 1 descendant cleared2023: 1 descendant cleared2024: 1 descendant cleared20052010201520202025
  1. This deviceK081347 Iluma VisionImtec Corp. · 2008
  2. Descendant · cites it directly · 24 of its ownK123519 Invivo DentalAnatomage, Inc. · 2013
  3. Descendant · 2 generations on · 14 of its ownK140713 Planmeca RomexisPlanmeca Oy · 2014
  4. Descendant · 3 generations on · 13 of its ownK162799 CliniviewPalodex Group OY · 2017
  5. Descendant · 4 generations on · 10 of its ownK203156 DTX Studio ClinicNobel Biocare AB · 2020
  6. Descendant · 5 generations on · 9 of its ownK213562 DTX Studio Clinic 3.0Nobel Biocare AB · 2022

Showing 5 of 26 descendants. See all descendants

Descendants cleared per year

2010: 12013: 12014: 32017: 22018: 32019: 12020: 32022: 12023: 12024: 12025: 32026: 6
2010high 6 (2026) · low 0 (2011)2026

Most influential descendants

Showing 5 of 26 · See all
  • K123519Invivo DentalAnatomage, Inc. · 2013 · cites it directly24descendants
  • K140713Planmeca RomexisPlanmeca Oy · 2014 · 2 generations on14descendants
  • K162799CliniviewPalodex Group OY · 2017 · 3 generations on13descendants
  • K203156DTX Studio ClinicNobel Biocare AB · 2020 · 4 generations on10descendants
  • K213562DTX Studio Clinic 3.0Nobel Biocare AB · 2022 · 5 generations on9descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K081347Iluma VisionImtec Corp.2008—
+1K123519Invivo DentalAnatomage, Inc.2013—
+2K140713Planmeca RomexisPlanmeca Oy2014—
+3K162799CliniviewPalodex Group OY2017—
+4K203156DTX Studio ClinicNobel Biocare AB2020—
+5K213562DTX Studio Clinic 3.0Nobel Biocare AB2022—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201010
201310
201430
201720
201830
201910
202030
202210
202310
202410
202530
202660
FIG. 1 — Lineage of K081347, 2008–2026Source: 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 510(k) statement (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?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (26)

See all 26

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

NumberDeviceApplicantDecidedDescendants
K123519Invivo DentalAnatomage, Inc.201324
K094064Iluma Vision Model Version 2.23M Imtec20100

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Aug 3, 2009Not classifiedZ-2239-2009Software designUnder certain circumstances, software Version 2.1.0 has potential for incorrect data imaging and patient identification.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K123519 (Anatomage, Inc., 2013) has gone furthest, with 24 descendants of its own.

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. 2008, 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?

ILUMA VISION is a software application used for the display and 3D visualization of medical image files from scanning devices, such as CT, MRI, or 3D Ultrasound. It is intended for use by radiologist, clinicians, referring physicians and other qualified individuals to retrieve, process, render, review, store, print, assist in diagnosis and distribute DICOM 3.0 compliant images, utilizing standard PC hardware. Additionally, ILUMA Vision is a preoperative software application used for the simulation and evaluation of dental implants, orthodontic planning and surgical treatments. The device is not intended for use with mammography.

Indications for use as stated in the FDA 510(k) statement.

More from Imtec Corp.

28 FDA decisions under this applicant name. See the company

  • K081653Mdi Mii One-Piece Implant, 2.9MMImtec Corp. · 20081 recall
  • K072660Endure Implant, Model 5108, 5111, 5113, 5114Imtec Corp. · 2007
  • K053046Iluma Orthocat/DentalcatImtec Corp. · 2005
  • K043226Endure Implant, Models 3508, 4308, 3520, 4320Imtec Corp. · 2005
  • K042289Mdi OrthoImtec Corp. · 2004

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/K081347 · printed Nov 6, 2026

Cite this page

510(k) Report. “K081347: Iluma Vision.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081347

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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