Terarecon Inc.

Address:39141 Civic Center Drive, Suite 240,Fremont,CA,94538,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

System, Image Processing, Radiological (LLZ) (7)

Premarket Exempt

No Yes

Clear

iNtuition - INTUITION3 Catalog Number :

Device Description : iNtuitionReview (aka iReview or AquariusNET Viewer) is a 2D/basic 3D image clien iNtuitionReview (aka iReview or AquariusNET Viewer) is a 2D/basic 3D image client viewer that provides multi-monitor and multi-modality image review.

Device Class : 2

Duns Number: 021677872

Premarket Exempt : No

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

iNtuition - INTUITION4 Catalog Number :

Device Description : iNtuitionEMV (aka iEMV) is a “zero footprint” 2D/basic 3D image client viewer ru iNtuitionEMV (aka iEMV) is a “zero footprint” 2D/basic 3D image client viewer running within a web browser. Limited to the context of iEMV usage on a mobile device, it is referred to as iEMV Mobile.

Device Class : 2

Duns Number: 021677872

Premarket Exempt : No

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

iNtuition - INTUITION5 Catalog Number :

Device Description : iNtuition Mobile (aka AQMobile) refers to the client viewer designed for mobile devices.

Device Class : 2

Duns Number: 021677872

Premarket Exempt : No

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

iNtuition - INTUITION6 Catalog Number :

Device Description : AquariusWeb Viewer (aka AqWeb or Web Viewer, marketing term) is a version of iNt AquariusWeb Viewer (aka AqWeb or Web Viewer, marketing term) is a version of iNtuitionEMV with a focus on 3D rendering, additionally providing workflow and scene support.

Device Class : 2

Duns Number: 021677872

Premarket Exempt : No

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

iNtuition - INTUITION7 Catalog Number :

Device Description : The AquariusNET Server, also known as iNtuition Server, receives, stores, transm The AquariusNET Server, also known as iNtuition Server, receives, stores, transmits and post-processes medical images from acquisition devices, in both DICOM and non-DICOM format.

Device Class : 2

Duns Number: 021677872

Premarket Exempt : No

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

Intuition - INTUITION8 Catalog Number :

Device Description : Intuition Client (aka Aquarius iNtuition Client, AQi, Aquarius Workstation, or A Intuition Client (aka Aquarius iNtuition Client, AQi, Aquarius Workstation, or Aquarius Workstation iNtuition Client) is the most comprehensive client viewer with 2D/3D/4D image processing and visualization capabilities.

Device Class : 2

Duns Number: 021677872

Premarket Exempt : No

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

Intuition - INTUITION9 Catalog Number :

Device Description : Intuition Thin Client (aka ThinClient and AquariusNET Viewer or AquariusNET Thin Intuition Thin Client (aka ThinClient and AquariusNET Viewer or AquariusNET ThinClient) is a client viewer with basic 2D/3D image viewing capabilities.

Device Class : 2

Duns Number: 021677872

Premarket Exempt : No

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

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