510(k) · Cleared
ClearedCMN Capillary Function with Virtual Expert for MRI, CT and CBCT
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 May 18, 2026 as substantially equivalent to K241989 (Cercare Medical A/S, 2024) after a 168-day review. Its family tree reaches back 15 generations to 1990.
- Decided
- May 18, 2026
- Review
- 168 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 15 generations to K896095 (1990). 16 ancestors in all. No later device cites it as a predicate yet.
- Root · 15 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
- 11 generations between
- 3 generations backK202793 Cercare Medical NeurosuiteCercare Medical Aps · 2021
- 2 generations backK230016 Cercare Medical NeurosuiteCercare Medical A/S · 2023
- 1 generation backK241989 Cercare Medical Neurosuite (CMN) Capillary Function with Virtual…Cercare Medical A/S · 2024
- This deviceK253831 CMN Capillary Function with Virtual Expert for MRI, CT and CBCTCercare Medical A/S · 2026
Show all 15 generations
- Root · 15 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
- 14 generations backK962699 Radworks Medical Imaging SoftwareApplicare Medical Imaging, B.V. · 1996
- 13 generations backK982862 Radworks Medical Imaging Software with Quality Control ModuleApplicare Medical Imaging, B.V. · 1998
- 12 generations backK012211 Efilm WorkstationEfilm Medical, Inc. · 2001 · Recalled
- 11 generations backK020995 Efilm Workstation with ModulesEfilm Medical, Inc. · 2002 · Recalled
- 10 generations backK063539 Nordic Image Control and Evaluation (Nice) Software, Version 2.1Nordicicemedical AS · 2007
- 9 generations backK082441 Nordicice SoftwareNordicimaginglab AS · 2008 · Recalled
- 8 generations backK090546 Modification to Nordicice SoftwareNordicimaginglab AS · 2009
- 7 generations backK111161 Perfscape V2.0Olea Medical · 2011
- 6 generations backK120196 Olea SphereOlea Medical · 2012
- 5 generations backK121447 Ischema View RapidIschemaview, Inc. · 2013
- 4 generations backK172477 iSchemaView RAPIDIschemaview, Inc. · 2018
- 3 generations backK202793 Cercare Medical NeurosuiteCercare Medical Aps · 2021
- 2 generations backK230016 Cercare Medical NeurosuiteCercare Medical A/S · 2023
- 1 generation backK241989 Cercare Medical Neurosuite (CMN) Capillary Function with Virtual…Cercare Medical A/S · 2024
- This deviceK253831 CMN Capillary Function with Virtual Expert for MRI, CT and CBCTCercare Medical A/S · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K896095 | Images-on-Call Teleradiology System | Devices & Services Co. | 1990 | — |
| −14 | K962699 | Radworks Medical Imaging Software | Applicare Medical Imaging, B.V. | 1996 | — |
| −13 | K982862 | Radworks Medical Imaging Software with Quality Control Module | Applicare Medical Imaging, B.V. | 1998 | — |
| −12 | K012211 | Efilm Workstation | Efilm Medical, Inc. | 2001 | 1 |
| −11 | K020995 | Efilm Workstation with Modules | Efilm Medical, Inc. | 2002 | 2 |
| −10 | K063539 | Nordic Image Control and Evaluation (Nice) Software, Version 2.1 | Nordicicemedical AS | 2007 | — |
| −9 | K082441 | Nordicice Software | Nordicimaginglab AS | 2008 | 2 |
| −8 | K090546 | Modification to Nordicice Software | Nordicimaginglab AS | 2009 | — |
| −7 | K111161 | Perfscape V2.0 | Olea Medical | 2011 | — |
| −6 | K120196 | Olea Sphere | Olea Medical | 2012 | — |
| −5 | K121447 | Ischema View Rapid | Ischemaview, Inc. | 2013 | — |
| −4 | K172477 | iSchemaView RAPID | Ischemaview, Inc. | 2018 | — |
| −3 | K202793 | Cercare Medical Neurosuite | Cercare Medical Aps | 2021 | — |
| −2 | 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 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K241989 | Cercare Medical Neurosuite (CMN) Capillary Function with Virtual ExpertSummary page 5…edicate Devices Predicate Device Manufacturer FDA 510(k) CMN Capillary Function with Virtual Expert for MRI Cercare Medical A/S K241989 and CT Device Description Cercare Medical Neurosuite is a software-only device designed to streamline medical image processing… | 2024 |
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 36 years and passes through 9 companies; a new generation was cleared every 2.2 years on median.
- 3 of the 16 ancestors have a recall of any class.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 (CMN) and associated modules is an image processing software package to be used by trained professionals, including physicians and medical technicians. The CMN 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)…
Read the full statement (296 words)
Cercare Medical Neurosuite (CMN) and associated modules is an image processing software package to be used by trained professionals, including physicians and medical technicians.
The CMN 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. CMN provides viewing capabilities of datasets acquired with MRI, CT, and Cone-Beam CT (CBCT).
The Capillary Function module provides analysis capabilities for functional and dynamic imaging datasets acquired with MRI, CT, or CBCT, including a Diffusion Weighted MRI (DWI) Module and a Dynamic Analysis Module (dynamic contrast-enhanced imaging data for MRI, CT or CBCT). 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. For MRI, 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.
For CT, one clinical application is to visualize the apparent blood perfusion and to calculate rCBF 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/K253831 · printed Nov 6, 2026
Cite this page
510(k) Report. “K253831: CMN Capillary Function with Virtual Expert for MRI, CT and CBCT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K253831
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026