See-Mode Augmented Reporting Tool, Thyroid (SMART-T)— 510(k) K240697

Name: FDA 510(k) clearance K240697
Creator: U.S. Food and Drug Administration
Published: 2024-09-09

Substantially Equivalent

See-Mode Technologies Pte, Ltd.

FDA 510(k) clearance K240697 for See-Mode Augmented Reporting Tool, Thyroid (SMART-T), Substantially Equivalent on 2024-09-09. Applicant: See-Mode Technologies Pte, Ltd.. Device class: 2.

Clearance details

Applicant: See-Mode Technologies Pte, Ltd.
Product code: Code QDQ
Device class: Class 2
Regulation: 21 CFR 892.2090
Advisory panel: Radiology
Date received: 2024-03-14
Decision date: 2024-09-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Singapore, SG

Download summary PDF View on FDA.gov ↗

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