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Cercare Medical Neurosuite (CMN) Capillary Function with Virtual Expert

FDA 510(k)FDA UDIEUDAMED

Class II (US FDA 510(k))

510(k) K241989Ref Capillary Function ver. 17Ref Capillary Function ver. 16Ref Capillary Function ver. 18Ref Virtual Expert ver. 18Ref Virtual Expert ver. 16

by Cercare Medical A/S

Identity

Trade Name
Capillary Function EUDAMED
Virtual Expert EUDAMED
Cercare Medical Neurosuite (CMN) Capillary Function with Virtual Expert FDA UDI
Cercare Medical Neurosuite with Capillary Function FDA UDI
Generic Name
Radiological PACS software FDA UDI
Device Name
Capillary Function EUDAMED
Virtual Expert EUDAMED
Cercare Medical Neurosuite (CMN) Capillary Function with Virtual Expert ver. 16 FDA UDI
Cercare Medical Neurosuite with Capillary Function ver. 16 FDA UDI
Cercare Medical Neurosuite with Capillary Function ver. 17 FDA UDI
Model / Reference
Capillary Function ver. 17 EUDAMED
Capillary Function ver. 16 EUDAMED
Capillary Function ver. 18 EUDAMED
Virtual Expert ver. 18 EUDAMED
Virtual Expert ver. 16 EUDAMED
16 FDA UDI
17 FDA UDI
Description
Cercare Medical Neurosuite (CMN) Capillary Function with Virtual Expert ver. 16 FDA UDI
Cercare Medical Neurosuite with Capillary Function ver. 16 FDA UDI
Cercare Medical Neurosuite with Capillary Function ver. 17 FDA UDI

Identifiers

Primary DI / UDI-DI
05745000308224 EUDAMEDFDA UDI
05745000308217 EUDAMEDFDA UDI
05745000308262 EUDAMEDFDA UDI
05745000308323 EUDAMED
05745000308330 EUDAMED
Basic UDI-DI
5745000308CMNCAPILLARYMC EUDAMED
5745000308CMNVIRTUALEXEH EUDAMED
Direct Marketing DI
05745000308262 EUDAMED
05745000308217 EUDAMED
05745000308323 EUDAMED
05745000308330 EUDAMED
05745000308224 EUDAMED
510(k) Number
K241989 FDA 510(k)FDA UDI
K202793 FDA UDI
K230016 FDA UDI
FDA Product Code
LLZ FDA 510(k)FDA UDI
EMDN Code
Z110603 PICTURE ARCHIVING AND COMMUNICATION SYSTEMS EUDAMED
Z11030592 RADIOLOGY INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
GMDN Term
Radiological PACS software FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class IIb EUDAMED
Class II FDA 510(k)FDA UDI
Legislation / Framework
21 CFR Part 892.2050 FDA 510(k)
Regulation Number
892.2050 FDA 510(k)FDA UDI
Special Device Type
Software EUDAMED
Market of Registration
Denmark EUDAMED
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

The Cercare Medical Neurosuite (CMN) Capillary Function with Virtual Expert is an image processing software package designed for advanced analysis of medical imaging data. Classified under product code LLZ and intended for use by trained professionals—such as physicians and medical technicians—it facilitates the post-processing, viewing, and analysis of images acquired from modalities like MRI. The software leverages virtual expert modules to derive actionable insights from biomarkers, supporting specialized workflows in neuroscience and oncology. Its functionality is rooted in computational analysis, enabling precise interpretation of perfusion and capillary function data.

This software is supplied as a standalone application compatible with standard off-the-shelf computers or virtual platforms such as VMware. It operates as a reusable, non-sterile digital tool, with no regulatory constraints on MRI safety as it does not incorporate physical components within the scan environment. The product holds FDA 510(k) clearance under the Radiology advisory committee and MDR conformity, ensuring compliance with both U.S. and European regulatory frameworks. No specific sterility or single-use requirements apply, as the software is intended for repeated use in clinical or research settings.

Frequently asked questions

What types of medical imaging data can the Cercare Medical Neurosuite (CMN) Capillary Function analyze, and how does it help clinicians interpret the results?

The CMN Capillary Function software is designed to analyze post-processed images from MRI modalities, specifically focusing on perfusion and capillary function data. It uses virtual expert modules to derive actionable insights from biomarkers, helping clinicians interpret complex imaging results in neuroscience and oncology workflows. This computational analysis supports precise interpretation of vascular health and tissue characteristics, aiding in specialized diagnostic decisions.

Is the Cercare Medical Neurosuite (CMN) Capillary Function software compatible with existing MRI systems, or does it require additional hardware?

The CMN Capillary Function operates as a standalone software application and does not require integration with MRI hardware during imaging. It is compatible with standard off-the-shelf computers or virtual platforms like VMware, meaning it can be installed on existing clinical or research systems without needing specialized MRI-compatible hardware. This makes it flexible for integration into workflows where MRI data is already being generated.

How is the software supplied, and what are the key considerations for installation and use in a clinical setting?

The software is supplied as a standalone digital package, meaning it is delivered electronically for installation on compatible computers or virtual environments like VMware. Since it is reusable and non-sterile, there are no restrictions on repeated use or sterilization requirements. Clinicians should ensure their systems meet the software’s compatibility standards (standard off-the-shelf computers or VMware) and that trained professionals, such as physicians or technicians, operate it to derive accurate insights from MRI-derived data.

Does the CMN Capillary Function software have any limitations regarding MRI safety, and how does it differ from physical MRI accessories?

Unlike physical devices placed within the MRI scan environment, the CMN Capillary Function software does not introduce any regulatory constraints on MRI safety. Since it is purely a digital tool used for post-processing and analysis outside the scanner, it does not require compliance with electromagnetic interference or radiofrequency safety standards. This distinction allows it to be used freely in MRI-equipped facilities without altering scan protocols or posing risks to patients or equipment.

What regulatory pathways does the Cercare Medical Neurosuite (CMN) Capillary Function follow, and how does this affect its use in the U.S. and Europe?

The software holds FDA 510(k) clearance under the Radiology advisory committee, demonstrating substantial equivalence to a predicate device, and it is also MDR-conformant for European markets. This means it meets U.S. and EU regulatory standards for safety and performance, allowing its use in clinical and research settings across both regions without additional approvals. The clearance under product code LLZ (Radiology) further confirms its intended use for advanced image analysis in specialized fields like neuroscience and oncology.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Cercare Medical Neurosuite (CMN) Capillary Function with Virtual Expert ..., https://cercare-medical.com, CMN Capillary Function with Oncology Virtual Expert

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Cercare Medical A/S

Sources (9)

  • FDA 510(k) K241989 24 fields · synced Sep 20, 2026
  • FDA UDI f459840f-63d3-43f3-9327-58530dfeb755 34 fields · synced May 30, 2026
  • FDA UDI 03e8aa81-12d9-47ec-9ef7-df33123638a9 34 fields · synced May 30, 2026
  • FDA UDI 76384629-8470-478f-bd1a-e319d0df1232 34 fields · synced May 30, 2026
  • EUDAMED f8a59300-dc84-417c-9a5f-0a7fc88b5f1d 61 fields · synced Jul 11, 2026
  • EUDAMED 20e37847-78ef-4a44-8a64-20afa8cb0e29 61 fields · synced Jul 13, 2026
  • EUDAMED 596ffee9-2965-4d77-b6b9-795dae55733f 61 fields · synced Jul 22, 2026
  • EUDAMED 26a48caf-1986-4ef6-b1a6-c3a9163bc3bb 61 fields · synced Jul 29, 2026
  • EUDAMED 4f3b9b34-5485-4a21-87a3-80c9adbeb8c4 61 fields · synced Aug 2, 2026