Rayvolve

GUDID 03770018071008

Rayvolve is a computer-assisted detection and diagnosis (CAD) software device to assist radiologists and emergency physicians in detecting fractures during the review of radiographs of the musculoskeletal system. Rayvolve is indicated for adult only. Rayvolve is indicated for radiographs of the following industry-standard radiographic views and study types. (Variant : On premise)

AZMED

X-ray image interpretive software

• Primary Device ID: 03770018071008
• NIH Device Record Key: 0f9e699b-0ee2-4702-b17e-70b7d0467572
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rayvolve
• Version Model Number: 2
• Company DUNS: 271425256
• Company Name: AZMED
• 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: true
• Serial Number: false
• Manufacturing Date: true
• 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	03770018071008 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220164

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: 2024-06-18
• Device Publish Date: 2024-06-10

On-Brand Devices [Rayvolve]

• 03770018071022: Rayvolve is a computer-assisted detection and diagnosis (CAD) software device to assist radiolog
• 03770018071015: Rayvolve is a computer-assisted detection and diagnosis (CAD) software device to assist radiolog
• 03770018071008: Rayvolve is a computer-assisted detection and diagnosis (CAD) software device to assist radiolog
• 03770018071084: Rayvolve is a computer-assisted detection and diagnosis (CAD) software device to assist radiolog
• 03770018071077: Rayvolve is a computer-assisted detection and diagnosis (CAD) software device to assist radiolog
• 03770018071060: Rayvolve is a computer-assisted detection and diagnosis (CAD) software device to assist radiolog