LineUP

GUDID 00863152000348

Weight Bearing CT Imaging for Foot, Ankle, and Knee. Non-Load Bearing imaging of upper extremities.

CURVEBEAM, LLC

Limited-view-field CT system

• Primary Device ID: 00863152000348
• NIH Device Record Key: 95ecc0e0-dd7e-4e74-bbd1-f00e40fcda2a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LineUP
• Version Model Number: 1030-115
• Company DUNS: 068780729
• Company Name: CURVEBEAM, LLC
• 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: true
• 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	00863152000348 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180727

FDA Product Code

• JAK: System, X-Ray, Tomography, Computed

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: 2018-10-11
• Device Publish Date: 2018-09-10

On-Brand Devices [LineUP]

• 00863152000355: Weight Bearing CT Imaging for Foot, Ankle, and Knee. Non-Load Bearing imaging of upper extremiti
• 00863152000348: Weight Bearing CT Imaging for Foot, Ankle, and Knee. Non-Load Bearing imaging of upper extremiti