| Primary Device ID | B621ICOBRAINCTP10 |
| NIH Device Record Key | 64d7d541-f711-481f-af64-dfc112d22661 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | icobrain ctp |
| Version Model Number | 1 |
| Company DUNS | 400793486 |
| Company Name | icometrix NV |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B621ICOBRAINCTP10 [Primary] |
| LLZ | System, Image Processing, Radiological |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-07-04 |
| Device Publish Date | 2022-06-24 |
| 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 |