510(k) Report

510(k) · Cleared

Cleared

Nordic Image Control and Evaluation (Nice) Software, Version 2.1

K063539510(k) TraditionalCleared Jan 17, 200754-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

Nordicicemedical AS · LLZ System, Image Processing, Radiological

Cleared on Jan 17, 2007 as substantially equivalent to K020995 (Efilm Medical, Inc., 2002) after a 54-day review. Its family tree reaches back 5 generations to 1990. 75 later devices descend from it.

Decided
Jan 17, 2007
Review
54 days
Class
Class II
Product code
LLZ
Recalls
None
Predicates
1

Its longest line of descent runs back 5 generations to K896095 (1990). 6 ancestors in all. 75 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1991: 1 other ancestor2009: 3 descendants cleared2008: 1 descendant cleared2013: 5 descendants cleared2012: 1 descendant cleared2011: 1 descendant cleared2022: 6 descendants cleared2017: 5 descendants cleared2014: 1 descendant cleared2016: 2 descendants cleared2021: 5 descendants cleared2015: 1 descendant cleared2024: 8 descendants cleared2023: 15 descendants cleared2019: 2 descendants cleared2018: 3 descendants cleared2025: 9 descendants cleared2020: 3 descendants cleared2026: 4 descendants clearedK896095 · Images-on-Call Teleradiology System · Devices & Services Co. · 1990K962699 · Radworks Medical Imaging Software · Applicare Medical Imaging, B.V. · 1996K982862 · Radworks Medical Imaging Software with Quality Control Module · Applicare Medical Imaging, B.V. · 1998K012211 · Efilm Workstation · Efilm Medical, Inc. · 2001 · recalledK020995 · Efilm Workstation with Modules · Efilm Medical, Inc. · 2002 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 5 generations back: 1 other ancestor 1 generation forward: 2 descendants2 generations forward: 1 descendant3 generations forward: 9 descendants4 generations forward: 10 descendants5 generations forward: 14 descendants6 generations forward: 19 descendants7 generations forward: 12 descendants8 generations forward: 4 descendants9 generations forward: 3 descendants10 generations forward: 1 descendant K020995 · Efilm Workstation with Modules · Efilm Medical, Inc. · 2002 · recalledK012211 · Efilm Workstation · Efilm Medical, Inc. · 2001 · recalledK982862 · Radworks Medical Imaging Software with Quality Control Module · Applicare Medical Imaging, B.V. · 1998K962699 · Radworks Medical Imaging Software · Applicare Medical Imaging, B.V. · 1996K896095 · Images-on-Call Teleradiology System · Devices & Services Co. · 1990−50+5+10
  1. Root · 5 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
  2. 4 generations backK962699 Radworks Medical Imaging SoftwareApplicare Medical Imaging, B.V. · 1996
  3. 3 generations backK982862 Radworks Medical Imaging Software with Quality Control ModuleApplicare Medical Imaging, B.V. · 1998
  4. 2 generations backK012211 Efilm WorkstationEfilm Medical, Inc. · 2001 · Recalled
  5. 1 generation backK020995 Efilm Workstation with ModulesEfilm Medical, Inc. · 2002 · Recalled
  6. This deviceK063539 Nordic Image Control and Evaluation (Nice) Software, Version 2.1Nordicicemedical AS · 2007
  7. Descendant · cites it directly · 73 of its ownK082441 Nordicice SoftwareNordicimaginglab AS · 2008 · Recalled
  8. Descendant · 2 generations on · 72 of its ownK090546 Modification to Nordicice SoftwareNordicimaginglab AS · 2009
  9. Descendant · 3 generations on · 53 of its ownK111161 Perfscape V2.0Olea Medical · 2011
  10. Descendant · 3 generations on · 51 of its ownK120196 Olea SphereOlea Medical · 2012
  11. Descendant · 4 generations on · 29 of its ownK121447 Ischema View RapidIschemaview, Inc. · 2013

Showing 5 of 75 descendants. See all descendants

Descendants cleared per year

2008: 12009: 32011: 12012: 12013: 52014: 12015: 12016: 22017: 52018: 32019: 22020: 32021: 52022: 62023: 152024: 82025: 92026: 4
2008high 15 (2023) · low 0 (2010)2026

Most influential descendants

Showing 5 of 75 · See all
  • K082441Nordicice SoftwareNordicimaginglab AS · 2008 · cites it directly73descendants
  • K090546Modification to Nordicice SoftwareNordicimaginglab AS · 2009 · 2 generations on72descendants
  • K111161Perfscape V2.0Olea Medical · 2011 · 3 generations on53descendants
  • K120196Olea SphereOlea Medical · 2012 · 3 generations on51descendants
  • K121447Ischema View RapidIschemaview, Inc. · 2013 · 4 generations on29descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K896095Images-on-Call Teleradiology SystemDevices & Services Co.1990—
−4K962699Radworks Medical Imaging SoftwareApplicare Medical Imaging, B.V.1996—
−3K982862Radworks Medical Imaging Software with Quality Control ModuleApplicare Medical Imaging, B.V.1998—
−2K012211Efilm WorkstationEfilm Medical, Inc.20011
−1K020995Efilm Workstation with ModulesEfilm Medical, Inc.20022
0 (this device)K063539Nordic Image Control and Evaluation (Nice) Software, Version 2.1Nordicicemedical AS2007—
+1K082441Nordicice SoftwareNordicimaginglab AS20082
+2K090546Modification to Nordicice SoftwareNordicimaginglab AS2009—
+3K111161Perfscape V2.0Olea Medical2011—
+3K120196Olea SphereOlea Medical2012—
+4K121447Ischema View RapidIschemaview, Inc.2013—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
200930
201110
201210
201350
201410
201510
201620
201750
201830
201920
202030
202150
202260
2023150
202480
202590
202640
FIG. 1 — Lineage of K063539, 1990–2026Source: 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 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
*K020995Efilm Workstation with Modules
Summary page 2
…d communication system Product Code LLZ 21 VFR Regulation 892.2050 3. PREDICATE DEVICE eFILM Workstation with Modules, K020995, Merge eMED, Inc. 4. DEVICE DESCRIPTION Nordic Image Control and Evaluation (nICE) Software is a medical imaging m…
Efilm Medical, Inc.20022

Also cleared against K020995: 14 other devices →

What descends from it? (75)

See all 75

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

NumberDeviceApplicantDecidedDescendants
K082441Nordicice SoftwareNordicimaginglab AS200873
K083491NeuroscapeOlea Medical20090

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 17 years and passes through 4 companies; a new generation was cleared every 2.8 years on median.
  • 2 of the 6 ancestors have a recall of any class.
  • Of its descendants, K082441 (Nordicimaginglab AS, 2008) has gone furthest, with 73 descendants of its own.
  • 14 other devices also cite its predicate K020995.

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. 2007, 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?

Nordic Image Control and Evaluation (nICE) Software is an image management system

intended to be used by trained professionals, including but not limited to physicians, nurses

and medical technicians. The system is used with general purpose computing hardware to

acquire, transmit, process and store images and data throughout a clinical environment. Data

and images are acquired through DICOM compliant imaging devices and modalities.

Lossy compressed mammographic images and digitized film screen images must not be

reviewed for primary image interpretations.

Indications for use as stated in the FDA summary.

Also cleared against K020995

14 other devices cite the same predicate.

  • K140797Ipacs Medical Image Management SystemVisbion Limited · 2014
  • K103679Axis Pacs, HMS PacsAxis Health Care, LLC · 2011
  • K102000ImagysKeosys Sas · 2010
  • K082135ShowcaseTrillium Technology, Inc. · 2008
  • K081304Alz Web Pacs, Version 1.0Alz, Inc. · 2008
  • K072960CDP 5000, Media and Distribution Center, DiagnetCdp, Ltd. · 20072 recalls

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/K063539 · printed Nov 4, 2026

Cite this page

510(k) Report. “K063539: Nordic Image Control and Evaluation (Nice) Software, Version 2.1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063539

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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