iNtuition

GUDID INTUITION6

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.

TERARECON, INC.

Radiology PACS software

• Primary Device ID: INTUITION6
• NIH Device Record Key: 04e6c540-dd39-468c-bcab-cc7c0f98f043
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iNtuition
• Version Model Number: Aquarius Web
• Company DUNS: 116929750
• Company Name: TERARECON, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	INTUITION6 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121916

FDA Product Code

• LLZ: System, Image Processing, Radiological

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2020-09-02
• Device Publish Date: 2016-09-21

On-Brand Devices [iNtuition]

• INTUITION7: The AquariusNET Server, also known as iNtuition Server, receives, stores, transmits and post-pro
• INTUITION6: AquariusWeb Viewer (aka AqWeb or Web Viewer, marketing term) is a version of iNtuitionEMV with a
• INTUITION5: iNtuition Mobile (aka AQMobile) refers to the client viewer designed for mobile devices.
• INTUITION4: iNtuitionEMV (aka iEMV) is a “zero footprint” 2D/basic 3D image client viewer running within
• INTUITION3: iNtuitionReview (aka iReview or AquariusNET Viewer) is a 2D/basic 3D image client viewer that pr
• INTUITION2: ThinClient (aka AquariusNET Viewer or AquariusNET ThinClient) is a client viewer with basic 2D/3
• INTUITION1: Aquarius iNtuition Client (aka AQi, Aquarius Workstation, or Aquarius Workstation iNtuition Clie
• INTUITION9: Intuition Thin Client (aka ThinClient and AquariusNET Viewer or AquariusNET ThinClient) is a cli
• INTUITION8: Intuition Client (aka Aquarius iNtuition Client, AQi, Aquarius Workstation, or Aquarius Workstat
• INTUITION12: The Intuition Server (aka AquariusNET Server and iNtuition Server) receives, stores, transmits a
• INTUITION11: Intuition Web (aka AquariusWeb Viewer and AqWeb or Web Viewer, marketing term) is a version of I
• INTUITION10: Intuition Mobile ( aka iNtuition Mobile and AQMobile) refers to the client viewer designed for m