See-Mode Technologies

GUDID 00860006305727

Localization and characterization of thyroid ultrasound images.

SEE-MODE TECHNOLOGIES PTE. LTD.

Ultrasound imaging system application software

• Primary Device ID: 00860006305727
• NIH Device Record Key: 1556f306-df2f-4917-aab7-67f031a9e398
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: See-Mode Technologies
• Version Model Number: See-Mode Augmented Reporting Tool, Thyroid (SMART-
• 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	00860006305727 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240697

FDA Product Code

• QDQ: Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer

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: 2024-12-02
• Device Publish Date: 2024-11-22

On-Brand Devices [See-Mode Technologies]

• 00860006305703: Analysis and reporting of vascular ultrasound images
• 00860006305727: Localization and characterization of thyroid ultrasound images.