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iNtuition iNtuitionReview

by Terarecon Inc.

iNtuition iNtuitionReview is a Class II device made by Terarecon Inc., cleared under FDA 510(k) K131447 on 24 Dec 2013 (2 earlier submissions) and listed in FDA GUDID since 21 Sep 2016 (UDI-DI INTUITION3), active as of 23 Oct 2026. One FDA recall is linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberINTUITION3 UDI-DI Date21 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK131447 Date24 Dec 2013DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K131447 decided 24 Dec 2013 Active· +2 more in the status table
  • FDA GUDID UDI-DI INTUITION3 listed 21 Sep 2016 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

5 dated events

  1. Cleared FDA 510(k) K012086
  2. Cleared FDA 510(k) K121916
  3. Cleared FDA 510(k) K131447
  4. Recall initiated FDA recalls Z-1070-2015
  5. Listed FDA GUDID INTUITION3

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
iNtuition
Generic name
Radiological PACS-dedicated management software
Model / reference
iNtuitionReview
Primary DI / UDI-DI
INTUITION3
510(k) Number
FDA product code
LLZ
GMDN term
Radiological PACS-dedicated management software
Device class
Class II
Regulation number
892.2050
GUDID distribution status
In Commercial Distribution

Related devices

Category: Radiological PACS software

Cleared under the same submission (K012086)

Cleared under the same submission (K121916)

and 8 more cleared under K121916

Similar devices in this category

Other devices filed under Radiological PACS software.

Other devices from Terarecon Inc.

See all devices from Terarecon Inc. →

Properties

  • Prescription use
  • Serial number
Other properties (13, all answered No)