510(k) · Cleared
ClearedNeuroscape
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olea Medical · LLZ System, Image Processing, Radiological
Cleared on Feb 19, 2009 as substantially equivalent to K063539 (Nordicicemedical AS, 2007) after an 86-day review. Its family tree reaches back 6 generations to 1990.
- Decided
- Feb 19, 2009
- Review
- 86 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K896095 (1990). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
- 5 generations backK962699 Radworks Medical Imaging SoftwareApplicare Medical Imaging, B.V. · 1996
- 4 generations backK982862 Radworks Medical Imaging Software with Quality Control ModuleApplicare Medical Imaging, B.V. · 1998
- 3 generations backK012211 Efilm WorkstationEfilm Medical, Inc. · 2001 · Recalled
- 2 generations backK020995 Efilm Workstation with ModulesEfilm Medical, Inc. · 2002 · Recalled
- 1 generation backK063539 Nordic Image Control and Evaluation (Nice) Software, Version 2.1Nordicicemedical AS · 2007
- This deviceK083491 NeuroscapeOlea Medical · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K896095 | Images-on-Call Teleradiology System | Devices & Services Co. | 1990 | — |
| −5 | K962699 | Radworks Medical Imaging Software | Applicare Medical Imaging, B.V. | 1996 | — |
| −4 | K982862 | Radworks Medical Imaging Software with Quality Control Module | Applicare Medical Imaging, B.V. | 1998 | — |
| −3 | K012211 | Efilm Workstation | Efilm Medical, Inc. | 2001 | 1 |
| −2 | K020995 | Efilm Workstation with Modules | Efilm Medical, Inc. | 2002 | 2 |
| −1 | K063539 | Nordic Image Control and Evaluation (Nice) Software, Version 2.1 | Nordicicemedical AS | 2007 | — |
| 0 (this device) | K083491 | Neuroscape | Olea Medical | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K063539 | Nordic Image Control and Evaluation (Nice) Software, Version 2.1Summary page 2…A cleared predicate device with regard to indications for use, performance and technological characteristics: 510(k) Number: K063539 Trade Name: Nordic Image Control and Evaluation (nICE) Software… | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
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 19 years and passes through 5 companies; a new generation was cleared every 2.8 years on median.
- 2 of the 7 ancestors have a recall of any class.
- 1 other device also cites its predicate K063539.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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?
NEUROSCAPE is a PACS image management software intended for use with general purpose computing hardware to acquire and process images and data throughout a clinical environrnent. Data and images are acquired through DICOM compliant 'imaging devices and modalities. The system is'used in hospitals, imaging centers and radiologist practices by medically trained professionals. NEUROSCAPE accepts data from existing MRi systems, allows the selection of regions…
Read the full statement (147 words)
NEUROSCAPE is a PACS image management software intended for use with general purpose computing hardware to acquire and process images and data throughout a clinical environrnent. Data and images are acquired through DICOM compliant 'imaging devices and modalities. The system is'used in hospitals, imaging centers and radiologist practices by medically trained professionals.
NEUROSCAPE accepts data from existing MRi systems, allows the selection of regions of interest as defined by a trained professional and provides a measurement of the areas or volumes associated with such selected regions. These measurements are normally used by the practitioner as an aid in the assessment of ischemic cerebral stroke patients.
NEUROSCAPE is fully integrated with most existing medical image visualization applications. The system is a multi-platform software running on any Windows or Linux operating systems.
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.
https://510kreport.com/device/K083491 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083491: Neuroscape.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083491
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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