TeraRecon Aorta.CT Aorta.CT

GUDID AORTACT01

TeraRecon Aorta.CT is intended to provide an automatic 3D segmentation and label anatomical landmarks of the Aorta. The results of TeraRecon Aorta.CT are intended to be used in conjunction with other patient information by trained professionals who are responsible for making any patient management decision per the standard of care.

Terarecon Inc.

Radiology DICOM image processing application software
Primary Device IDAORTACT01
NIH Device Record Key1692f211-e9d8-4648-aa23-9a37eaa686a4
Commercial Distribution StatusIn Commercial Distribution
Brand NameTeraRecon Aorta.CT
Version Model NumberAorta.CT01
Catalog NumberAorta.CT
Company DUNS021677872
Company NameTerarecon Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCAORTACT01 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QIHAutomated Radiological Image Processing Software

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-02-18
Device Publish Date2025-02-10

Devices Manufactured by Terarecon Inc.

AORTACT01 - TeraRecon Aorta.CT2025-02-18TeraRecon Aorta.CT is intended to provide an automatic 3D segmentation and label anatomical landmarks of the Aorta. The results of TeraRecon Aorta.CT are intended to be used in conjunction with other patient information by trained professionals who are responsible for making any patient management decision per the standard of care.
AORTACT01 - TeraRecon Aorta.CT2025-02-18 TeraRecon Aorta.CT is intended to provide an automatic 3D segmentation and label anatomical landmarks of the Aorta. The results
NEURO02 - TeraRecon Neuro2023-12-04 TeraRecon Neuro allows motion correction and processes, calculates and outputs brain perfusion analysis results for functional,
AQAPS04 - AQAPS2021-09-15 AQAPS, also known as AquariusAPS Server, is a stand-alone medical device software which performs various kinds of data processin
INTUITION04 - Intuition2021-09-15 Intuition (also referred to as Aquarius Intuition) is a medical device comprised of two stand-alone software components: a serve

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