FDA 510(k) Application Details - K013054

Device Classification Name	Solid State X-Ray Imager (Flat Panel/Digital Imager)   More FDA Info for this Device
510(K) Number	K013054
Device Name	Solid State X-Ray Imager (Flat Panel/Digital Imager)
Applicant	KONICA MINOLTA MEDICAL & GRAPHIC, INC. 2970 ISHIKAWA-CHO HACHIOJI-SHI TOKYO 192-8505 JP Other 510(k) Applications for this Company
Contact	KOJI KUBO 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	09/11/2001
Decision Date	03/01/2002
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