Aorta-CAD

GUDID 00852491008030

Aorta-CAD is a computer-assisted detection (CADe) software device that analyzes chest radiograph studies for suspicious regions of interest (ROIs). The device uses a deep learning algorithm to identify ROIs and produces boxes around the ROIs. The boxes are labeled with one of the following radiographic findings: Aortic calcification or Dilated aorta. Aorta-CAD is intended for use as a concurrent reading aid for physicians looking for ROIs with radiographic findings suggestive of Aortic Atherosclerosis or Aortic Ectasia. It does not replace the role of the physician or of other diagnostic testing in the standard of care. Aorta-CAD is indicated for adults only.

Imagen Technologies, Inc.

X-ray image interpretive software

• Primary Device ID: 00852491008030
• NIH Device Record Key: 940d768e-b45a-4697-b5de-57e2c234559b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aorta-CAD
• Version Model Number: 1.0.0
• Company DUNS: 042356781
• Company Name: Imagen Technologies, 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00852491008030 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213353

FDA Product Code

• MYN: Analyzer, Medical Image

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: 2023-04-14
• Device Publish Date: 2023-04-06

Devices Manufactured by Imagen Technologies, Inc.

• 00852491008030 - Aorta-CAD: 2023-04-14Aorta-CAD is a computer-assisted detection (CADe) software device that analyzes chest radiograph studies for suspicious regions of interest (ROIs). The device uses a deep learning algorithm to identify ROIs and produces boxes around the ROIs. The boxes are labeled with one of the following radiographic findings: Aortic calcification or Dilated aorta. Aorta-CAD is intended for use as a concurrent reading aid for physicians looking for ROIs with radiographic findings suggestive of Aortic Atherosclerosis or Aortic Ectasia. It does not replace the role of the physician or of other diagnostic testing in the standard of care. Aorta-CAD is indicated for adults only.
• 00852491008030 - Aorta-CAD: 2023-04-14 Aorta-CAD is a computer-assisted detection (CADe) software device that analyzes chest radiograph studies for suspicious regions
• 00852491008023 - Chest-CAD: 2021-08-03 Chest-CAD is a computer-assisted detection (CADe) software device designed as a concurrent reading aid to physicians. Chest-CAD
• 00852491008016 - FractureDetect (FX): 2021-04-20 FractureDetect (FX) is a computer-assisted detection and diagnosis (CAD) software device to assist clinicians in detecting fract