FDA 510(k) Application Details - K121418

Device Classification Name	System, X-Ray, Tomography, Computed   More FDA Info for this Device
510(K) Number	K121418
Device Name	System, X-Ray, Tomography, Computed
Applicant	PLANMED OY Sorvaajankatu 7 Helsinki 00880 FI Other 510(k) Applications for this Company
Contact	LARS MORING 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	05/11/2012
Decision Date	02/01/2013
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