FDA 510(k) Application Details - K952190

Device Classification Name	System, Tomography, Computed, Emission   More FDA Info for this Device
510(K) Number	K952190
Device Name	System, Tomography, Computed, Emission
Applicant	SOPHA MEDICAL SYSTEMS, INC. 14900 SWEITZER LN. SUITE 200 LAUREL, MD 20707 US Other 510(k) Applications for this Company
Contact	LONNIE MIXON Other 510(k) Applications for this Contact
Regulation Number	892.1200   More FDA Info for this Regulation Number
Classification Product Code	KPS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/09/1995
Decision Date	01/18/1996
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