SOFIA

GUDID 00863522000008

IVU IMAGING CORPORATION

Breast ultrasound imaging system

• Primary Device ID: 00863522000008
• NIH Device Record Key: a393eba9-2ac3-4d91-a5e7-263709144069
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SOFIA
• Version Model Number: SOFIA
• Company DUNS: 005104440
• Company Name: IVU IMAGING CORPORATION
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00863522000008 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080555

FDA Product Code

• IYO: System, Imaging, Pulsed Echo, Ultrasonic

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: 2020-02-13
• Device Publish Date: 2020-02-05