FDA 510(k) Application Details - K240009

Device Classification Name	System, X-Ray, Mobile   More FDA Info for this Device
510(K) Number	K240009
Device Name	System, X-Ray, Mobile
Applicant	First Source Inc. 3495 Winton Place, Building E, Suite 1 Rochester, NY 14623 US Other 510(k) Applications for this Company
Contact	Woo Sung Park Other 510(k) Applications for this Contact
Regulation Number	892.1720   More FDA Info for this Regulation Number
Classification Product Code	IZL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/02/2024
Decision Date	07/03/2024
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