FDA 510(k) Application Details - K964288

Device Classification Name	Digitizer, Image, Radiological   More FDA Info for this Device
510(K) Number	K964288
Device Name	Digitizer, Image, Radiological
Applicant	PC TELERADIOLOGY 3519 E. ARCATA RD. SALT LAKE CITY, UT 84124 US Other 510(k) Applications for this Company
Contact	G.N. BALDWIN, M.D. Other 510(k) Applications for this Contact
Regulation Number	892.2030   More FDA Info for this Regulation Number
Classification Product Code	LMA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/28/1996
Decision Date	04/23/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review