FDA 510(k) Application Details - K243250

Device Classification Name	More FDA Info for this Device
510(K) Number	K243250
Device Name	SubtleHD (1.x)
Applicant	Subtle Medical, Inc. 883 Santa Cruz Ave Suite 205 Menlo Park, CA 94025 US Other 510(k) Applications for this Company
Contact	Ronny Elor 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	10/15/2024
Decision Date	02/12/2025
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