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 |
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 |
B621ICOBRAIN60 - icobrain | 2022-07-04 |
B621ICOBRAINCTP10 - icobrain ctp | 2022-07-04 |
B621ICOBRAINCTP10 - icobrain ctp | 2022-07-04 |
B621ICOBRAIN50 - icobrain | 2020-02-25 |
B621ICOBRAIN40 - icobrain | 2019-10-07 |
B621ICOBRAIN20 - icobrain | 2019-10-07 icobrain is software intended for automatic labeling, visualization and volumetric quantification of segmentable brain structure |