FDA 510(k) Application Details - K040224

Device Classification Name	System, X-Ray, Tomography, Computed   More FDA Info for this Device
510(K) Number	K040224
Device Name	System, X-Ray, Tomography, Computed
Applicant	PRAXIM INC 486 HIGH PLAIN ST. WALPOLE, MA 02081 US Other 510(k) Applications for this Company
Contact	CHRISTINE MEEHAN Other 510(k) Applications for this Contact
Regulation Number	892.1750   More FDA Info for this Regulation Number
Classification Product Code	JAK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/02/2004
Decision Date	04/06/2004
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