TeraRecon Cardiovascular.Calcification.CT CardiovascCalCT1

GUDID CARDIOVASCCALCT1

TeraRecon Cardiovascular.Calcification.CT is intended to provide an automatic 3D segmentation of calcified plaques within the coronary arteries and outputs a mask for calcium scoring systems to use for calculations. The results of TeraRecon Cardiovascular.Calcification.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 ID: CARDIOVASCCALCT1
• NIH Device Record Key: 4f8efc00-1e6a-4134-9639-b2d9afeef4c5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TeraRecon Cardiovascular.Calcification.CT
• Version Model Number: Cardiovascular.Calcification.CT01
• Catalog Number: CardiovascCalCT1
• 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 Identifiers

Device Issuing Agency	Device ID
HIBCC	CARDIOVASCCALCT1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K250288

FDA Product Code

• QIH: Automated Radiological Image Processing Software

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: 2026-02-02
• Device Publish Date: 2026-01-23

Devices Manufactured by Terarecon Inc.

• CARDIOVASCCALCT1 - TeraRecon Cardiovascular.Calcification.CT: 2026-02-02TeraRecon Cardiovascular.Calcification.CT is intended to provide an automatic 3D segmentation of calcified plaques within the coronary arteries and outputs a mask for calcium scoring systems to use for calculations. The results of TeraRecon Cardiovascular.Calcification.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.
• CARDIOVASCCALCT1 - TeraRecon Cardiovascular.Calcification.CT: 2026-02-02 TeraRecon Cardiovascular.Calcification.CT is intended to provide an automatic 3D segmentation of calcified plaques within the co
• 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,
• 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