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icobrain ctp 1

by icometrix NV

icobrain ctp 1 is a medical device (FDA Class II; FDA product code LLZ, System, Image Processing, Radiological) made by icometrix NV, cleared under FDA 510(k) K192962 on 28 Feb 2020, registered in EUDAMED and listed in FDA GUDID since 24 Jun 2022 (UDI-DI B621ICOBRAINCTP10), active as of 23 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K192962↗

FDA record

Trust

Unverified

Source EUDAMED, FDA 510(k), GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID NumberB621ICOBRAINCTP10 UDI-DI Date24 Jun 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) 510(k) NumberK192962 Date28 Feb 2020IssuedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Official records

Across registries

3 registries list this device

  • FDA 510(k) K192962 decided 28 Feb 2020 Active
  • EUDAMED Active
  • FDA GUDID UDI-DI B621ICOBRAINCTP10 listed 24 Jun 2022 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K192962
  2. Listed FDA GUDID B621ICOBRAINCTP10

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • United States FDA 510(k) Active
  • European Union CE/MDR Active

Specification

EUDAMED · 510(k) · GUDID

Trade name
icobrain ctp
Generic name
Radiology DICOM image processing application software
Model / reference
1
Primary DI / UDI-DI
B621ICOBRAINCTP10
510(k) Number
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

Related devices

Category: Radiology DICOM image processing application software

Cleared under the same submission (K192962)

Similar devices in this category

Other devices filed under Radiology DICOM image processing application software.

Other devices from icometrix NV

See all devices from icometrix NV →

Properties

Other properties (15, all answered No)