FDA 510(k) Application Details - K241717

Device Classification Name	More FDA Info for this Device
510(K) Number	K241717
Device Name	E1000 Dx Digital Pathology Solution
Applicant	Shandon Diagnostics Limited Tudor Road, Manor Park, Cheshire Runcorn WA7 1TA GB Other 510(k) Applications for this Company
Contact	Naveen Kaki Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PSY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/14/2024
Decision Date	02/28/2025
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