FDA 510(k) Application Details - K240740

Device Classification Name	More FDA Info for this Device
510(K) Number	K240740
Device Name	qCT LN Quant
Applicant	Qure.ai Technologies Level 7, Commerz II International Business Park Oberoi Garden City, Goregaon (E) Mumbai 400 063 IN Other 510(k) Applications for this Company
Contact	Abishamala Kingsly Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QIH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/18/2024
Decision Date	08/16/2024
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