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ClariCT.AI ClariCT.ACE

by ClariPI Inc.

ClariCT.AI ClariCT.ACE is a Class II device made by ClariPI Inc., cleared under FDA 510(k) K212074 on 27 Jul 2021, registered in EUDAMED and listed in FDA GUDID since 27 Nov 2024 (UDI-DI 08800046800211), active as of 23 Oct 2026.

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

CE MDD 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) K212074

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number08800046800211 UDI-DI Date27 Nov 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) GUDID from GUDID NumberK212074 Date27 Jul 2021IssuedStatusActive
European UnionCE/MDD EUDAMED Number— Date—StatusActive

Official records

Across registries

3 registries list this device

  • FDA 510(k) K212074 decided 27 Jul 2021 Active
  • EUDAMED Active
  • FDA GUDID UDI-DI 08800046800211 listed 27 Nov 2024 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K212074
  2. Listed FDA GUDID 08800046800211

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
ClariCT.AI
Generic name
Radiology DICOM image processing application software
Model / reference
ClariCT.ACE
Primary DI / UDI-DI
08800046800211
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 (K212074)

Similar devices in this category

Other devices filed under Radiology DICOM image processing application software.

Other devices from ClariPI Inc.

  • ClariCT.AI 1.3.3

    Class II

  • ClariCT.AI 1.1.0

    Class II

  • ClariCT.AI ClariPET-CT

    Class II

  • ClariSIGMAM 1.1.7

    Class II

See all devices from ClariPI Inc. →

Properties

  • Prescription use
  • Lot / batch number
  • Serial number
Other properties (12, all answered No)