icobrain aria

Primary DI
B621ICOBRAINARIA1X2Y0
Brand
icobrain aria
Company
icometrix NV
Model
1.2
Device description
icobrain aria is a computer-assisted detection (CADe) and diagnosis (CADx) software device to be used as a concurrent reading aid to help trained radiologists in the detection, assessment and characterization of Amyloid Related Imaging Abnormalities (ARIA) from a set of brain MR images. The software provides information about the presence, location, size, severity and changes of ARIA-E (brain edema or sulcal effusions) and ARIA-H (hemosiderin deposition, including microhemorrhage and superficial siderosis). Patient management decisions should not be made solely on the basis of analysis by icobrain aria
Published
2025-10-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true

Product Codes#

Code, Name table
CodeName
QBSRadiological Computer Assisted Detection/Diagnosis Software For Fracture

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QBSRadiological Computer Assisted Detection/Diagnosis Software For FractureRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K240712000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K240712000icobrain ariaIcometrix NV2024-11-07QBS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B621ICOBRAINARIA1X2Y0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Radiology DICOM image processing application softwareA software application intended to facilitate management, distribution, and/or viewing of radiological digital imaging and communications in medicine (DICOM) image data; it is not intended for pathological image interpretation (i.e., not intended to detect and localize suspected abnormalities). It may be intended to facilitate image management (e.g., viewing, communication, printing, recording/disc burning) and/or image quality manipulation and quantification (e.g., non-interpretive graphical overlays).

Regulatory Flags#

DUNS number
400793486
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B621ICOBRAINMR5X17Y0icobrain mr5.172025-09-19
B621ICOBRAINARIA1X1Y0icobrain aria1.12025-02-18
B621ICOBRAINCT6X4Y0icobrain ct6.42024-10-11
B621ICOBRAINMR5X16Y0icobrain mr5.162024-08-06
B621ICOMPANION2X2Y0icompanion2.22024-06-07
B621ICOBRAINMR5X15Y0icobrain mr5.152024-05-29
B621ICOMPANION2X1Y0icompanion2.12024-02-08
B621ICOBRAINMR5X14Y0icobrain mr5.142023-12-08
B621ICOBRAIN60icobrain62022-06-24
B621ICOBRAINCTP10icobrain ctp12022-06-24
B621ICOBRAIN50icobrain52020-02-17
B621ICOBRAIN40icobrain4.02019-04-08
B621ICOBRAIN20icobrain22018-01-29
B621ICOBRAIN30icobrain32018-03-19
B621ICOMPANION103icompanion12023-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03770018071121RayvolveAZMEDQBS2026-06-04
03770018071138RayvolveAZMEDQBS2026-06-04
03770018071145RayvolveAZMEDQBS2026-06-04
03770024774047TechCare TraumaMILVUEQBS2025-03-31
B621ICOBRAINARIA1X1Y0icobrain ariaicometrix NVQBS2025-02-18
03770018071060RayvolveAZMEDQBS2024-10-11
03770018071077RayvolveAZMEDQBS2024-10-11
03770018071084RayvolveAZMEDQBS2024-10-11
03770018071008RayvolveAZMEDQBS2024-06-10
03770018071015Rayvolve AZMEDQBS2024-03-18
03770018071022RayvolveAZMEDQBS2024-03-18
00195278789365Critical Care SuiteGE Medical Systems, L.L.C.QBS2023-10-19
03770020839085BoneViewGLEAMERQBS2023-03-16
03770020839009BoneViewGLEAMERQBS2022-04-20
00852491008016FractureDetect (FX)Imagen Technologies, Inc.QBS2021-04-12