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Intuition Intuition04

by Terarecon Inc.

Ref Intuition

Intuition Intuition04 is a device classified as Class IIa in the EU and Class II in the US made by Terarecon Inc., registered in EUDAMED on 29 Jan 2024 (Basic UDI-DI B-INTUITION04), cleared under FDA 510(k) K191585 on 12 Jul 2019 (3 earlier submissions) and listed in FDA GUDID since 7 Sep 2021 (UDI-DI INTUITION04), active as of 25 Oct 2026. One FDA recall is linked to it.

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 ongoing

1 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K191585

+3 more

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-INTUITION04 Basic UDI-DI INTUITION04UDI-DIDate29 Jan 2024RegisteredStatusActive
United StatesGUDID listing GUDID NumberINTUITION04 UDI-DI Date7 Sep 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK191585 Date12 Jul 2019DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-INTUITION04 registered 29 Jan 2024 Active
  • FDA 510(k) K191585 decided 12 Jul 2019 Active· +3 more in the status table
  • FDA GUDID UDI-DI INTUITION04 listed 7 Sep 2021 Listed

Recalls

1 recall · FDA

    • Terminated Z-1070-2015 FDA Class II initiated 21 Jan 2015

    Software anomaly related to RECIST1.1 target lesion evaluation criteria in Findings Workflow Module within the Aquarius iNtuition Client Viewer.

Timeline

7 dated events

  1. Cleared FDA 510(k) K121916
  2. Cleared FDA 510(k) K131447
  3. Recall initiated FDA recalls Z-1070-2015
  4. Cleared FDA 510(k) K180916
  5. Cleared FDA 510(k) K191585
  6. Listed FDA GUDID INTUITION04
  7. Registered EUDAMED B-INTUITION04

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  • Withdrawn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
Intuition
Generic name
Radiology DICOM image processing application software
Model / Ref / Catalog
Intuition, Intuition04
Primary DI / UDI-DI
INTUITION04
Basic UDI-DI
B-INTUITION04
510(k) Number
FDA product code
LLZ
EMDN code
Z11030592 Radiology instruments - medical device software
GMDN term
Radiology DICOM image processing application software
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
892.2050
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
Intuition
GUDID
Intuition04
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Radiology DICOM image processing application software

Cleared under the same submission (K121916)

and 8 more cleared under K121916

Cleared under the same submission (K131447)

and 8 more cleared under K131447

Similar devices in this category

Other devices filed under RADIOLOGY INSTRUMENTS - MEDICAL DEVICE SOFTWARE.

Other devices from Terarecon Inc.

See all devices from Terarecon Inc. →

Properties

  • Serial number
Other properties (22, all answered No)