FDA 510(k) Application Details - K243234

Device Classification Name	Analyzer,Medical Image   More FDA Info for this Device
510(K) Number	K243234
Device Name	Analyzer,Medical Image
Applicant	Pearl Inc. 2515 Benedict Canyon Dr. Beverly Hills, CA 90210 US Other 510(k) Applications for this Company
Contact	William Birdsall Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	MYN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/10/2024
Decision Date	06/12/2025
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