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icobrain ctp
FDA UDIFDA 510(k)EUDAMEDClass II (US FDA UDI)
510(k) K192962
by Icometrix NV
Identity
- Trade Name
- icobrain ctp FDA UDI
- Generic Name
- Radiology DICOM image processing application software FDA UDI
- Model / Reference
- 1 FDA UDI
Identifiers
- Primary DI / UDI-DI
- B621ICOBRAINCTP10 FDA UDI
- 510(k) Number
- K192962 FDA UDI
- FDA Product Code
- LLZ FDA UDI
- GMDN Term
- Radiology DICOM image processing application software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.2050 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Radiology DICOM image processing application software
icobrain ctp by Icometrix NV — Class II — FDA_510K, MDR — listed in FDA GUDID, FDA 510(k), EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Unknown
MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K192962 | Class II | Active |
| EUDAMED | European Union | MDR | — | Class II | Unknown |
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Manufacturer
- Manufacturer
- Icometrix NV
Sources (3)
- FDA UDI 64d7d541-f711-481f-af64-dfc112d22661 57 fields · synced Jun 18, 2026
- FDA 510(k) K192962 1 fields · synced Jun 4, 2026
- EUDAMED 1 fields · synced Jun 4, 2026