VEA Align

GUDID 03663999000290

EOS IMAGING

Basic diagnostic x-ray system application software Basic diagnostic x-ray system application software Basic diagnostic x-ray system application software Basic diagnostic x-ray system application software Basic diagnostic x-ray system application software Basic diagnostic x-ray system application software Basic diagnostic x-ray system application software Basic diagnostic x-ray system application software Basic diagnostic x-ray system application software Basic diagnostic x-ray system application software Basic diagnostic x-ray system application software Basic diagnostic x-ray system application software Basic diagnostic x-ray system application software Basic diagnostic x-ray system application software Basic diagnostic x-ray system application software Basic diagnostic x-ray system application software

• Primary Device ID: 03663999000290
• NIH Device Record Key: 6db36f9c-7969-4fed-a833-db1fe086ad5b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VEA Align
• Version Model Number: 1.0
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	03663999000290 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K231917

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-06-06
• Device Publish Date: 2024-05-29

Devices Manufactured by EOS IMAGING

• 03663999000290 - VEA Align: 2024-06-06
• 03663999000290 - VEA Align: 2024-06-06
• 03663999000184 - spineEOS: 2024-02-23
• 03663999000153 - sterEOS: 2024-02-22
• 03663999000061 - Radiolucent Chair: 2023-07-18
• 03663999000160 - spineEOS: 2023-07-18
• 03663999000177 - hipEOS: 2023-07-18
• 03663999000191 - EOS Portal: 2023-07-18
• 03663999000108 - EOSedge™: 2020-03-06