FDA 510(k) Application Details - K042386

Device Classification Name	Solid State X-Ray Imager (Flat Panel/Digital Imager)   More FDA Info for this Device
510(K) Number	K042386
Device Name	Solid State X-Ray Imager (Flat Panel/Digital Imager)
Applicant	KONICA MINOLTA MEDICAL & GRAPHIC, INC. PROGRESS SECTION 319 AKENO, OBATA-CHO WATARAI-GUN; MIE-KEN 519-05 JP Other 510(k) Applications for this Company
Contact	SHINICHI YAMANAKA Other 510(k) Applications for this Contact
Regulation Number	892.1650   More FDA Info for this Regulation Number
Classification Product Code	MQB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/02/2004
Decision Date	12/15/2004
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