icobrain 4.0
by icometrix NV
icobrain 4.0 is a medical device (FDA Class II; FDA product code LLZ, System, Image Processing, Radiological) made by icometrix NV, listed in FDA GUDID since 8 Apr 2019 (UDI-DI B621ICOBRAIN40), registry data as of 23 Oct 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | NumberB621ICOBRAIN40 | Date8 Apr 2019 | StatusListed |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- icobrain
- Generic name
- Radiology DICOM image processing application software
- Model / reference
- 4.0
- Primary DI / UDI-DI
- B621ICOBRAIN40
- FDA product code
- LLZ
- GMDN term
- Radiology DICOM image processing application software
- Device class
- Class II
- Regulation number
- 892.2050
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Radiology DICOM image processing application software.
- CAAS MR Solutions 5.3 by Pie Medical Imaging B.V.
- Advanced Visualization Workspace 881120 by Philips Medical Systems Nederland B.V.
- RConsole1 1.0 by Drtech Corp.
- CAAS Workstation 8.5.3 by Pie Medical Imaging B.V.
- Quantra 2.2 R2LIC-2103-V2.2 by Hologic
- Corridor4DM C4DM10 by Invia
- CINA-iPE 1.0 by AVICENNA.AI
- EConsole1 by Drtech Corp.
- EDDA TECHNOLOGY IQQA-BodyImaging by EDDA Technology, Inc.
- Vitrea Software Toshiba Package VSTP-001A by CANON INC.