FDA 510(k) Application Details - K241275

Device Classification Name	More FDA Info for this Device
510(K) Number	K241275
Device Name	Histolog« Scanner (Hardware 2.4, Software 3.3)
Applicant	SamanTree Medical SA Avenue de Provence 12 Lausanne 1007 CH Other 510(k) Applications for this Company
Contact	Olivier Delporte Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OWN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/06/2024
Decision Date	08/19/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review