AquariusAPS

GUDID AQAPS1

The AquariusAPS server is a stand-alone medical device software which performs various kinds of data processing on incoming DICOM data sets, according

TERARECON, INC.

Radiology picture archiving and communication system application software Radiology picture archiving and communication system application 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 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: AQAPS1
• NIH Device Record Key: d3047dc2-e60f-41c5-b7ae-d5649f8208bc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AquariusAPS
• Version Model Number: AquariusAPS
• Company DUNS: 021677872
• 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	AQAPS1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K061214

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: 4
• Public Version Date: 2018-09-24
• Device Publish Date: 2016-09-21

Devices Manufactured by TERARECON, INC.

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• INTUITION10 - Intuition: 2020-12-02 Intuition Mobile ( aka iNtuition Mobile and AQMobile) refers to the client viewer designed for mobile devices.
• INTUITION11 - Intuition: 2020-12-02 Intuition Web (aka AquariusWeb Viewer and AqWeb or Web Viewer, marketing term) is a version of Intuition EMV (aka iNtuitionEMV)
• INTUITION12 - Intuition: 2020-12-02 The Intuition Server (aka AquariusNET Server and iNtuition Server) receives, stores, transmits and post-processes medical images
• INTUITION8 - Intuition: 2020-12-02 Intuition Client (aka Aquarius iNtuition Client, AQi, Aquarius Workstation, or Aquarius Workstation iNtuition Client) is the mos
• INTUITION9 - Intuition: 2020-12-02 Intuition Thin Client (aka ThinClient and AquariusNET Viewer or AquariusNET ThinClient) is a client viewer with basic 2D/3D imag
• INTUITION1 - iNtuition: 2020-09-02 Aquarius iNtuition Client (aka AQi, Aquarius Workstation, or Aquarius Workstation iNtuition Client) is the most comprehensive cl