FDA 510(k) Application Details - K242838

Device Classification Name	System, Image Processing, Radiological   More FDA Info for this Device
510(K) Number	K242838
Device Name	System, Image Processing, Radiological
Applicant	Aikenist Technologies Pvt Ltd 15/A, 2nd Floor, 10th Main, 22nd Cross 3rd Block, Jayanagar Bengaluru 560011 IN Other 510(k) Applications for this Company
Contact	Ashwin Amarapuram Chandramouly Other 510(k) Applications for this Contact
Regulation Number	892.2050   More FDA Info for this Regulation Number
Classification Product Code	LLZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/19/2024
Decision Date	02/21/2025
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