AutoDensity

GUDID 03663999000436

EOS IMAGING

Basic diagnostic x-ray system application software

• Primary Device ID: 03663999000436
• NIH Device Record Key: 7d7bb002-8862-4edf-b4fe-d8a58509eff5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AutoDensity
• Version Model Number: 1.3
• 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	03663999000436 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K251078

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: 2025-12-17
• Device Publish Date: 2025-12-09

Devices Manufactured by EOS IMAGING

• 03663999000436 - AutoDensity: 2025-12-17
• 03663999000436 - AutoDensity: 2025-12-17
• 03663999000375 - spineEOS: 2025-08-11
• 03663999000412 - VEA Align: 2025-08-11
• 03663999000405 - EOSedge: 2025-05-22
• 03663999000139 - EOSedge chair: 2025-02-07
• 03663999000306 - VEA Portal: 2025-02-07
• 03663999000337 - VEA Align: 2024-07-15
• 03663999000313 - spineEOS: 2024-07-10