iNtuition

GUDID INTUITION1

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

TERARECON, INC.

Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software

• Primary Device ID: INTUITION1
• NIH Device Record Key: 25efb793-e46d-4072-82db-a709af9a0f74
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iNtuition
• Version Model Number: Aquarius iNtuition Client
• 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	INTUITION1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K011142

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