FDA 510(k) Application Details - K102196

Device Classification Name	X-Ray, Tomography, Computed, Dental   More FDA Info for this Device
510(K) Number	K102196
Device Name	X-Ray, Tomography, Computed, Dental
Applicant	VATECH CO., LTD. 333 MEADOWLANDS PARKWAY #303 SECAUCUS, NJ 07094 US Other 510(k) Applications for this Company
Contact	DAVE KIM Other 510(k) Applications for this Contact
Regulation Number	892.1750   More FDA Info for this Regulation Number
Classification Product Code	OAS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/29/2010
Decision Date	03/25/2011
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