See-Mode Technologies

GUDID 00860006305703

Analysis and reporting of vascular ultrasound images

SEE-MODE TECHNOLOGIES PTE. LTD.

Ultrasound imaging system application software

• Primary Device ID: 00860006305703
• NIH Device Record Key: 252cf853-90e0-4067-b82b-18ded47eaac7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: See-Mode Technologies
• Version Model Number: AVA (Augmented Vascular Analysis)
• Company DUNS: 659470225
• Company Name: SEE-MODE TECHNOLOGIES PTE. LTD.
• 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: 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	00860006305703 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201369

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: 2023-08-24
• Device Publish Date: 2023-08-16