Chest-CAD

GUDID 00852491008023

Chest-CAD is a computer-assisted detection (CADe) software device designed as a concurrent reading aid to physicians. Chest-CAD uses machine learning techniques to identify, highlight, and categorize suspicious regions of interest (ROI) in adult chest X-rays. Any suspicious ROI identified by Chest-CAD is assigned to one of the following categories: Cardiac, Mediastinum/Hila, Lungs, Pleura, Bones, Soft Tissues, Hardware, or Other. 00852491008016

Imagen Technologies, Inc.

X-ray image interpretive software

• Primary Device ID: 00852491008023
• NIH Device Record Key: a81de5fc-71ec-4706-94c7-db187cf585d3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Chest-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	00852491008023 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210666

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: 2021-08-03
• Device Publish Date: 2021-07-26

Devices Manufactured by Imagen Technologies, Inc.

• 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: 2021-08-03Chest-CAD is a computer-assisted detection (CADe) software device designed as a concurrent reading aid to physicians. Chest-CAD uses machine learning techniques to identify, highlight, and categorize suspicious regions of interest (ROI) in adult chest X-rays. Any suspicious ROI identified by Chest-CAD is assigned to one of the following categories: Cardiac, Mediastinum/Hila, Lungs, Pleura, Bones, Soft Tissues, Hardware, or Other. 00852491008016
• 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