FDA 510(k) Application Details - K042674

Device Classification Name	Colon Computed Tomography System, Computer Aided Detection   More FDA Info for this Device
510(K) Number	K042674
Device Name	Colon Computed Tomography System, Computer Aided Detection
Applicant	MEDICSIGHT 46 BERKELEY SQUARE LONDON W 1J 5AT GB Other 510(k) Applications for this Company
Contact	CAROL MACDONALD Other 510(k) Applications for this Contact
Regulation Number	892.2050   More FDA Info for this Regulation Number
Classification Product Code	NWE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/29/2004
Decision Date	10/19/2004
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review