FDA 510(k) Application Details - K241108

Device Classification Name	More FDA Info for this Device
510(K) Number	K241108
Device Name	RemedyLogic AI MRI Lumbar Spine Reader
Applicant	Remedy Logic Inc. 1177 Avenue of the Americas, 5th Floor New York, NY 10036 US Other 510(k) Applications for this Company
Contact	Andrej Rusakov 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	04/22/2024
Decision Date	10/30/2024
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