# icobrain ctp 1

> Active: European Union and United States. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/icobrain-ctp-1>
- Manufacturer: [icometrix NV](https://devicerts.com/manufacturers/icometrix-nv) (Belgium)
- Device class: Class II (US FDA)
- FDA product code: LLZ
- GMDN: Radiology DICOM image processing application software (57812)

## Registrations and authorizations

- **GUDID** · GUDID listing · United States · UDI-DI B621ICOBRAINCTP10 · listed 2022-06-24 · status: Listed (GUDID: in commercial distribution)
- **510(k)** · FDA 510(k) · United States · K192962 · issued 2020-02-28 · status: Active
- **EUDAMED** · CE/MDR · European Union · status: Active

## Recalls

No recall on record.

## Identity

- Trade name: icobrain ctp [FDA GUDID (AccessGUDID)]
- Generic name: Radiology DICOM image processing application software [FDA GUDID (AccessGUDID)]
- Model / reference: 1 [FDA GUDID (AccessGUDID)]

## Identifiers

- Primary DI / UDI-DI: B621ICOBRAINCTP10 [FDA GUDID (AccessGUDID)]
- 510(k) Number: K192962 [FDA GUDID (AccessGUDID)]
- FDA product code: LLZ [FDA GUDID (AccessGUDID)]
- GMDN term: Radiology DICOM image processing application software (57812) [FDA GUDID (AccessGUDID)]

## Classification

- Device class: Class II [FDA GUDID (AccessGUDID)]
- Regulation number: 892.2050 [FDA GUDID (AccessGUDID)]
- GUDID distribution status: In Commercial Distribution [FDA GUDID (AccessGUDID)]

## Properties

- Supplied sterile: No [FDA GUDID (AccessGUDID)]
- Sterilise before use: No [FDA GUDID (AccessGUDID)]
- Single use: No [FDA GUDID (AccessGUDID)]
- Implantable: No [FDA GUDID (AccessGUDID)]
- Contains latex: No [FDA GUDID (AccessGUDID)]
- Prescription use: No [FDA GUDID (AccessGUDID)]
- Over-the-counter: No [FDA GUDID (AccessGUDID)]
- Convenience kit: No [FDA GUDID (AccessGUDID)]
- Combination product: No [FDA GUDID (AccessGUDID)]
- HCT/P: No [FDA GUDID (AccessGUDID)]
- Premarket exempt: No [FDA GUDID (AccessGUDID)]
- Lot / batch number: No [FDA GUDID (AccessGUDID)]
- Serial number: No [FDA GUDID (AccessGUDID)]
- Expiration date: No [FDA GUDID (AccessGUDID)]
- Manufacturing date: No [FDA GUDID (AccessGUDID)]

## Source and citation

- Cite as: icobrain ctp 1, icometrix NV. deviCERTS medical device catalogue. https://devicerts.com/devices/icobrain-ctp-1 (data as of 2026-11-15).
- Data sources: [FDA GUDID (AccessGUDID)](https://accessgudid.nlm.nih.gov/), [FDA 510(k)](https://open.fda.gov/apis/device/510k/), [EUDAMED](https://ec.europa.eu/tools/eudamed)
- Registry records last synced: 2026-10-23
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/icobrain-ctp-1.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/icobrain-ctp-1
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.