FDA 510(k) Application Details - K061449

Device Classification Name System, X-Ray, Tomography, Computed

  More FDA Info for this Device
510(K) Number K061449
Device Name System, X-Ray, Tomography, Computed
Applicant SIEMENS MEDICAL SOLUTION
51 VALLEY STREAM PKWY. E-50
MALVERN, PA 19355 US
Other 510(k) Applications for this Company
Contact GARY JOHNSON
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 05/25/2006
Decision Date 07/25/2006
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



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact