FDA 510(k) Application Details - K013897

Device Classification Name	Solid State X-Ray Imager (Flat Panel/Digital Imager)   More FDA Info for this Device
510(K) Number	K013897
Device Name	Solid State X-Ray Imager (Flat Panel/Digital Imager)
Applicant	BIO-SCAN S.A 153 SANFORD LN. STAMFORD, CT 06905 US Other 510(k) Applications for this Company
Contact	RICHARD M SANO 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	11/23/2001
Decision Date	05/21/2002
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review