FDA 510(k) Application Details - K231666

Device Classification Name	Transducer, Ultrasonic, Diagnostic   More FDA Info for this Device
510(K) Number	K231666
Device Name	Transducer, Ultrasonic, Diagnostic
Applicant	Fujifilm Healthcare Americas Corporation 81 Hartwell Avenue Suite 300 Lexington, MA 02421 US Other 510(k) Applications for this Company
Contact	Chaitrali Kulkarni Other 510(k) Applications for this Contact
Regulation Number	892.1570   More FDA Info for this Regulation Number
Classification Product Code	ITX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/07/2023
Decision Date	12/13/2023
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