FDA 510(k) Application Details - K240697

Device Classification Name	More FDA Info for this Device
510(K) Number	K240697
Device Name	See-Mode Augmented Reporting Tool, Thyroid (SMART-T)
Applicant	See-Mode Technologies Pte. Ltd. 32 Carpenter Street, #03-01 Singapore 059911 SG Other 510(k) Applications for this Company
Contact	Sadaf Monajemi Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QDQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/14/2024
Decision Date	09/09/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review