Primary Device ID | AORTACT01 |
NIH Device Record Key | 1692f211-e9d8-4648-aa23-9a37eaa686a4 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | TeraRecon Aorta.CT |
Version Model Number | Aorta.CT01 |
Catalog Number | Aorta.CT |
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 | false |
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 Issuing Agency | Device ID |
---|---|
HIBCC | AORTACT01 [Primary] |
QIH | Automated Radiological Image Processing Software |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2025-02-18 |
Device Publish Date | 2025-02-10 |
AORTACT01 - TeraRecon Aorta.CT | 2025-02-18TeraRecon 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.CT | 2025-02-18 TeraRecon Aorta.CT is intended to provide an automatic 3D segmentation and label anatomical landmarks of the Aorta. The results |
NEURO02 - TeraRecon Neuro | 2023-12-04 TeraRecon Neuro allows motion correction and processes, calculates and outputs brain perfusion analysis results for functional, |
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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 |