FDA 510(k) Application Details - K243391

Device Classification Name	More FDA Info for this Device
510(K) Number	K243391
Device Name	AISight Dx
Applicant	PathAI, Inc. 1325 Boylston Avenue Suite 10000 Boston, MA 02215 US Other 510(k) Applications for this Company
Contact	Hisani Madison Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QKQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/31/2024
Decision Date	06/26/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	PA - Pathology
Review Advisory Committee	PA - Pathology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review