FDA 510(k) Application Details - K243989

Device Classification Name	More FDA Info for this Device
510(K) Number	K243989
Device Name	Second Opinion« 3D
Applicant	Pearl, Inc. 2515 Benedict Canyon Dr. Beverly Hills, CA 90210 US Other 510(k) Applications for this Company
Contact	Ashley Brown 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	12/26/2024
Decision Date	05/23/2025
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