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FDA 510(k)

See-Mode Augmented Reporting Tool, Thyroid (SMART-T)

K-Number: K240697 · 2024-09-09

ApplicantSee-Mode Technologies Pte, Ltd.
Decision Date2024-09-09
Product CodeQDQ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

See-Mode Augmented Reporting Tool, Thyroid (SMART-T) is a medical device manufactured by See-Mode Technologies Pte, Ltd.. It received FDA 510(k) clearance on 2024-09-09 under approval number K240697. The device is classified under product code QDQ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the See-Mode Augmented Reporting Tool, Thyroid (SMART-T)?

See-Mode Augmented Reporting Tool, Thyroid (SMART-T) is a medical device that received FDA 510(k) clearance on 2024-09-09. It is manufactured by See-Mode Technologies Pte, Ltd.. The 510(k) number is K240697.

When was See-Mode Augmented Reporting Tool, Thyroid (SMART-T) approved by the FDA?

See-Mode Augmented Reporting Tool, Thyroid (SMART-T) received FDA 510(k) clearance on 2024-09-09, under approval number K240697.

What company makes See-Mode Augmented Reporting Tool, Thyroid (SMART-T)?

See-Mode Augmented Reporting Tool, Thyroid (SMART-T) is manufactured by See-Mode Technologies Pte, Ltd..

What is the FDA product code for See-Mode Augmented Reporting Tool, Thyroid (SMART-T)?

The FDA product code for See-Mode Augmented Reporting Tool, Thyroid (SMART-T) is QDQ.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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