BoneView

GUDID 03770020839085

GLEAMER

Radiology PACS software

• Primary Device ID: 03770020839085
• NIH Device Record Key: 861d336a-8efd-41e0-a8fd-917c6d123604
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BoneView
• Version Model Number: 1.1.X
• Company DUNS: 277185191
• Company Name: GLEAMER
• 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: true
• 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
GS1	03770020839085 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222176

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: 2023-03-24
• Device Publish Date: 2023-03-16

On-Brand Devices [BoneView]

• 03770020839009: 1.X-US
• 03770020839085: 1.1.X