AQAPS AQAPS

GUDID AQAPS04

AQAPS, also known as AquariusAPS Server, is a stand-alone medical device software which performs various kinds of data processing on incoming DICOM data sets, according to user pre-configured rules and schedules.

Terarecon Inc.

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• Primary Device ID: AQAPS04
• NIH Device Record Key: 33dda6be-599e-42c5-a34a-43f2067a3106
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AQAPS
• Version Model Number: AQAPS04
• Catalog Number: AQAPS
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	AQAPS04 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-09-15
• Device Publish Date: 2021-09-07

Devices Manufactured by Terarecon Inc.

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• AQAPS04 - AQAPS: 2021-09-15AQAPS, also known as AquariusAPS Server, is a stand-alone medical device software which performs various kinds of data processing on incoming DICOM data sets, according to user pre-configured rules and schedules.
• AQAPS04 - AQAPS: 2021-09-15 AQAPS, also known as AquariusAPS Server, is a stand-alone medical device software which performs various kinds of data processin
• INTUITION04 - Intuition: 2021-09-15 Intuition (also referred to as Aquarius Intuition) is a medical device comprised of two stand-alone software components: a serve