cNeuro cPET

No FDA recalls found in the data synced 22 Oct 2026.

Generic Name

Radiology DICOM image processing application software

Model / Reference

cNeuro cPET EUDAMED

1.0.x GUDID

Primary DI / UDI-DI

06430070844015

Basic UDI-DI

6430070844027Y

510(k) Number

K231576 ↗

FDA Product Code

KPS

EMDN Code

V92 Medical device software - not included in other classes

GMDN Term

Radiology DICOM image processing application software

Device Class

Class IIa EUDAMED

Class II 510(k)GUDID

Regulation

21 CFR Part 892.1200

Special Device Type

Software

EU market of registration

Finland

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

GUDID distribution status

In Commercial Distribution

• cNeuro cMRI

  Class IIa

  CE/MDR FI22/871878 Active Valid to Feb 2030 GUDID on market

• cNeuro cDAT

  Class IIa

  CE/MDR FI22/871878 Active Valid to Feb 2030 FDA 510(k) K233908 Active Cleared 1 Jul 2024 +1authorizations

• cNeuro cDSI

  Class IIa

  CE/MDD CE/MDR FI22/871878 Active Valid to Feb 2030

• What clinical application does the cNeuro cPET system primarily support in brain imaging?

  The cNeuro cPET system is designed to quantify amyloid load in the brain using positron emission tomography (PET) imaging. It provides relative comparisons against a normal reference database to help assess neurodegenerative changes, such as those seen in conditions like Alzheimer’s disease. The system also integrates PET imaging with MRI co-registration to improve diagnostic clarity by correlating functional PET findings with anatomical MRI data.

• How is the cNeuro cPET system supplied, and what does its licensing model entail?

  The cNeuro cPET is supplied as a software-based solution for analysis and visualization, intended for use in radiology settings. Its usage model depends on the imaging modality and software licensing—it can be used with single-use or reusable components, though no explicit sterility requirements are stated. The licensing model implies flexibility in deployment, allowing integration with existing PET and MRI systems.

• What regulatory pathways has the cNeuro cPET system undergone, and where is it authorized for use?

  The cNeuro cPET has received FDA 510(k) clearance and MDR (Medical Device Regulation) authorization, confirming its compliance with both U.S. and European Union regulatory standards. These authorizations validate its safety and performance for the intended use in PET imaging and amyloid load assessment, ensuring it meets the requirements of Class II medical devices under FDA regulations.

• Does the cNeuro cPET system have any specific safety considerations for MRI compatibility?

  While the cNeuro cPET integrates PET imaging with MRI co-registration to enhance diagnostic accuracy, the provided data does not explicitly detail MRI safety classifications (e.g., MRI conditional status). Users should verify compatibility with their specific MRI system and follow manufacturer guidelines to ensure safe operation in an MRI environment.

• What types of facilities or departments would benefit most from implementing the cNeuro cPET system?

  The cNeuro cPET is specifically designed for radiology departments, particularly those specializing in neurological imaging. Clinicians and facilities focused on diagnosing neurodegenerative diseases, such as Alzheimer’s or other amyloid-related conditions, would find it most valuable. Its integration with MRI co-registration also supports multidisciplinary teams, including neurologists and radiologists, in obtaining comprehensive diagnostic insights.