FDA 510(k) Application Details - K230899

Device Classification Name	More FDA Info for this Device
510(K) Number	K230899
Device Name	qXR-PTX-PE
Applicant	Qure.ai Technologies Level 7, Commerz II, International Business Park Oberoi Garden City, Goregaon (E) Mumbai 400063 IN Other 510(k) Applications for this Company
Contact	Ayushi Mahendra Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QFM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/31/2023
Decision Date	08/22/2023
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