icobrain aria

GUDID B621ICOBRAINARIA1X1Y0

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

icometrix NV

Radiology DICOM image processing application software

• Primary Device ID: B621ICOBRAINARIA1X1Y0
• NIH Device Record Key: a6e87f98-85b7-472c-a3cf-db2e9f74d459
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: icobrain aria
• Version Model Number: 1.1
• Company DUNS: 400793486
• Company Name: icometrix NV
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B621ICOBRAINARIA1X1Y0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240712

FDA Product Code

• QBS: Radiological Computer Assisted Detection/Diagnosis Software For Fracture

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-02-26
• Device Publish Date: 2025-02-18

Devices Manufactured by icometrix NV

• B621ICOBRAINARIA1X1Y0 - icobrain aria: 2025-02-26icobrain 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
• B621ICOBRAINARIA1X1Y0 - icobrain aria: 2025-02-26 icobrain aria is a computer-assisted detection (CADe) and diagnosis (CADx) software device to be used as a concurrent reading ai
• B621ICOBRAINCT6X4Y0 - icobrain ct: 2024-10-21 icobrain mr is intended for automatic labeling, visualization and volumetric quantification of segmentable brain structures from
• B621ICOBRAINMR5X16Y0 - icobrain mr: 2024-08-14 icobrain mr is intended for automatic labeling, visualization and volumetric quantification of segmentable brain structures from
• B621ICOMPANION2X2Y0 - icompanion: 2024-06-17
• B621ICOBRAINMR5X15Y0 - icobrain mr: 2024-06-06 icobrain mr is intended for automatic labeling, visualization and volumetric quantification of segmentable brain structures from
• B621ICOMPANION2X1Y0 - icompanion: 2024-02-16
• B621ICOBRAINMR5X14Y0 - icobrain mr: 2023-12-18 icobrain mr is intended for automatic labeling, visualization and volumetric quantification of segmentable brain structures from
• B621ICOMPANION103 - icompanion: 2023-10-02