VEA Align

GUDID 03663999000412

EOS IMAGING

Basic diagnostic x-ray system application software

• Primary Device ID: 03663999000412
• NIH Device Record Key: c527bbbe-e37a-46a9-99de-fbcba515858e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VEA Align
• Version Model Number: 3.x
• Company DUNS: 762320968
• Company Name: EOS IMAGING
• 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: 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	03663999000412 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240582

FDA Product Code

• QIH: Automated Radiological Image Processing Software

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2025-08-11
• Device Publish Date: 2025-08-01

On-Brand Devices [VEA Align]

• 03663999000290: 1.0
• 03663999000337: 2.1
• 03663999000412: 3.x