FDA 510(k) Application Details - K061715

Device Classification Name	Coil, Magnetic Resonance, Specialty   More FDA Info for this Device
510(K) Number	K061715
Device Name	Coil, Magnetic Resonance, Specialty
Applicant	INSIGHTEC TXSONICS, INC. 2777 STEMMONS FREEWAY STE 940 DALLAS, TX 75207-2273 US Other 510(k) Applications for this Company
Contact	Nadir Alikacem Other 510(k) Applications for this Contact
Regulation Number	892.1000   More FDA Info for this Regulation Number
Classification Product Code	MOS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/19/2006
Decision Date	07/28/2006
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