sterEOS

GUDID 03663999000153

EOS IMAGING

Radiology DICOM image processing application software

• Primary Device ID: 03663999000153
• NIH Device Record Key: dbeba98a-3ddb-47d4-ac0c-46ac8ab91025
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: sterEOS
• Version Model Number: 1.10
• 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	03663999000153 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172346

FDA Product Code

• LLZ: System, Image Processing, Radiological

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: 2024-02-22
• Device Publish Date: 2024-02-14

Devices Manufactured by EOS IMAGING

• 03663999000337 - VEA Align: 2024-07-15
• 03663999000313 - spineEOS: 2024-07-10
• 03663999000290 - VEA Align: 2024-06-06
• 03663999000184 - spineEOS: 2024-02-23
• 03663999000153 - sterEOS: 2024-02-22
• 03663999000153 - sterEOS: 2024-02-22
• 03663999000061 - Radiolucent Chair: 2023-07-18
• 03663999000160 - spineEOS: 2023-07-18
• 03663999000177 - hipEOS: 2023-07-18