FDA 510(k) Application Details - K103645

Device Classification Name	Transducer, Ultrasonic, Diagnostic   More FDA Info for this Device
510(K) Number	K103645
Device Name	Transducer, Ultrasonic, Diagnostic
Applicant	TOSHIBA MEDICAL SYSTEMS CORPORATION, JAPAN 2441 MICHELLE DR TUSTIN, CA 92780 US Other 510(k) Applications for this Company
Contact	PAUL BIGGINS 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	12/13/2010
Decision Date	01/12/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review