FractureDetect (FX)

GUDID 00852491008016

FractureDetect (FX) is a computer-assisted detection and diagnosis (CAD) software device to assist clinicians in detecting fractures during the review of radiographs of the musculoskeletal system. FX is indicated for adults only.

Imagen Technologies, Inc.

X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software

• Primary Device ID: 00852491008016
• NIH Device Record Key: 9b8bff47-11fb-45ef-9409-8b76e24a9d5a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FractureDetect (FX)
• 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	00852491008016 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193417

FDA Product Code

• QBS: Radiological Computer Assisted Detection/Diagnosis Software For Fracture

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: 2021-04-20
• Device Publish Date: 2021-04-12

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: 2021-08-03 Chest-CAD is a computer-assisted detection (CADe) software device designed as a concurrent reading aid to physicians. Chest-CAD
• 00852491008016 - FractureDetect (FX): 2021-04-20FractureDetect (FX) is a computer-assisted detection and diagnosis (CAD) software device to assist clinicians in detecting fractures during the review of radiographs of the musculoskeletal system. FX is indicated for adults only.
• 00852491008016 - FractureDetect (FX): 2021-04-20 FractureDetect (FX) is a computer-assisted detection and diagnosis (CAD) software device to assist clinicians in detecting fract