FDA 510(k) Application Details - K223757

Device Classification Name	More FDA Info for this Device
510(K) Number	K223757
Device Name	Bonelogic
Applicant	Disior Ltd HTC Helsinki Building PINTA 4 Floor Tammasaarenkatu 3 Helsinki 00180 FI Other 510(k) Applications for this Company
Contact	Aarno Jussila 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	12/15/2022
Decision Date	12/08/2023
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