510(k) · Cleared
ClearedCercare Medical Neurosuite
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cercare Medical A/S · LLZ System, Image Processing, Radiological
Cleared on Jul 14, 2023 as substantially equivalent to K202793 (Cercare Medical Aps, 2021) after a 192-day review. Its family tree reaches back 13 generations to 1990. 2 later devices descend from it.
- Decided
- Jul 14, 2023
- Review
- 192 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 13 generations to K896095 (1990). 14 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 13 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
- 9 generations between
- 3 generations backK121447 Ischema View RapidIschemaview, Inc. · 2013
- 2 generations backK172477 iSchemaView RAPIDIschemaview, Inc. · 2018
- 1 generation backK202793 Cercare Medical NeurosuiteCercare Medical Aps · 2021
- This deviceK230016 Cercare Medical NeurosuiteCercare Medical A/S · 2023
- Descendant · cites it directly · 1 of its ownK241989 Cercare Medical Neurosuite (CMN) Capillary Function with Virtual…Cercare Medical A/S · 2024
- Descendant · 2 generations on · 0 of its ownK253831 CMN Capillary Function with Virtual Expert for MRI, CT and CBCTCercare Medical A/S · 2026
Show all 13 generations
- Root · 13 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
- 12 generations backK962699 Radworks Medical Imaging SoftwareApplicare Medical Imaging, B.V. · 1996
- 11 generations backK982862 Radworks Medical Imaging Software with Quality Control ModuleApplicare Medical Imaging, B.V. · 1998
- 10 generations backK012211 Efilm WorkstationEfilm Medical, Inc. · 2001 · Recalled
- 9 generations backK020995 Efilm Workstation with ModulesEfilm Medical, Inc. · 2002 · Recalled
- 8 generations backK063539 Nordic Image Control and Evaluation (Nice) Software, Version 2.1Nordicicemedical AS · 2007
- 7 generations backK082441 Nordicice SoftwareNordicimaginglab AS · 2008 · Recalled
- 6 generations backK090546 Modification to Nordicice SoftwareNordicimaginglab AS · 2009
- 5 generations backK111161 Perfscape V2.0Olea Medical · 2011
- 4 generations backK120196 Olea SphereOlea Medical · 2012
- 3 generations backK121447 Ischema View RapidIschemaview, Inc. · 2013
- 2 generations backK172477 iSchemaView RAPIDIschemaview, Inc. · 2018
- 1 generation backK202793 Cercare Medical NeurosuiteCercare Medical Aps · 2021
- This deviceK230016 Cercare Medical NeurosuiteCercare Medical A/S · 2023
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K896095 | Images-on-Call Teleradiology System | Devices & Services Co. | 1990 | — |
| −12 | K962699 | Radworks Medical Imaging Software | Applicare Medical Imaging, B.V. | 1996 | — |
| −11 | K982862 | Radworks Medical Imaging Software with Quality Control Module | Applicare Medical Imaging, B.V. | 1998 | — |
| −10 | K012211 | Efilm Workstation | Efilm Medical, Inc. | 2001 | 1 |
| −9 | K020995 | Efilm Workstation with Modules | Efilm Medical, Inc. | 2002 | 2 |
| −8 | K063539 | Nordic Image Control and Evaluation (Nice) Software, Version 2.1 | Nordicicemedical AS | 2007 | — |
| −7 | K082441 | Nordicice Software | Nordicimaginglab AS | 2008 | 2 |
| −6 | K090546 | Modification to Nordicice Software | Nordicimaginglab AS | 2009 | — |
| −5 | K111161 | Perfscape V2.0 | Olea Medical | 2011 | — |
| −4 | K120196 | Olea Sphere | Olea Medical | 2012 | — |
| −3 | K121447 | Ischema View Rapid | Ischemaview, Inc. | 2013 | — |
| −2 | K172477 | iSchemaView RAPID | Ischemaview, Inc. | 2018 | — |
| −1 | K202793 | Cercare Medical Neurosuite | Cercare Medical Aps | 2021 | — |
| 0 (this device) | K230016 | Cercare Medical Neurosuite | Cercare Medical A/S | 2023 | — |
| +1 | K241989 | Cercare Medical Neurosuite (CMN) Capillary Function with Virtual Expert | Cercare Medical A/S | 2024 | — |
| +2 | K253831 | CMN Capillary Function with Virtual Expert for MRI, CT and CBCT | Cercare Medical A/S | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2026 | 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.
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K241989 | Cercare Medical Neurosuite (CMN) Capillary Function with Virtual Expert | 2024 | 1 |
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 33 years and passes through 9 companies; a new generation was cleared every 2.2 years on median.
- 3 of the 14 ancestors have a recall of any class.
- Of its descendants, K241989 (Cercare Medical A/S, 2024) has gone furthest, with 1 descendant of its own.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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?
Cercare Medical Neurosuite and associated modules, including the Capillary Function module, is an image processing software package to be used by trained professionals, including physicians and medical technicians. The software package runs on standard off-the-shelf computer or a virtual platform, such as VMware, and can be used to perform image viewing, processing, and analysis of images. Data and images are acquired through DICOM (Digital Imaging and…
Read the full statement (252 words)
Cercare Medical Neurosuite and associated modules, including the Capillary Function module, is an image processing software package to be used by trained professionals, including physicians and medical technicians.
The software package runs on standard off-the-shelf computer or a virtual platform, such as VMware, and can be used to perform image viewing, processing, and analysis of images. Data and images are acquired through DICOM (Digital Imaging and Communications in Medicine) compliant imaging devices
Cercare Medical Neurosuite provides viewing capabilities, whereas the Capillary Function module provides analysis capabilities for functional and dynamic imaging datasets acquired with MRI including a Diffusion Weighted MRI (DWI) Module and a Dynamic Analysis Module (dynamic contrast-enhanced imaging data for MRI).
The Capillary Function module is used for visualization and analysis of dynamic imaging data, showing properties of changes in contrast over time. This functionality includes calculation of parameters related to tissue flow (perfusion) and tissue blood volume. In addition, the Capillary Function module’s DWI technology is used to visualize local water diffusion properties from the analysis of diffusion-weighted MRI data.
The Virtual Expert module allows the calculation of regions of interest and the visual inspection of time attenuation curves. One clinical application is to visualize the apparent blood perfusion and diffusion and to calculate ADC threshold volume, Tmax threshold volume, and Mismatch Ratio in the brain tissue affected by acute stroke.
Areas of decreased perfusion appear as areas of changed signal intensity:
• Lower signal intensity for CBF and CBV
• Higher signal intensity for TTP, MTT, and Tmax
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230016 · printed Nov 6, 2026
Cite this page
510(k) Report. “K230016: Cercare Medical Neurosuite.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K230016
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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