| Device Classification Name |
System, X-Ray, Tomography, Computed
More FDA Info for this Device |
| 510(K) Number |
K120300 |
| Device Name |
System, X-Ray, Tomography, Computed |
| Applicant |
ACTIVIEWS LTD
555 THIRTEENTH STREET, NW
WASHINGTON, DC 20004 US
Other 510(k) Applications for this Company
|
| Contact |
John j Smith, M.D., J.D.
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 |
01/31/2012 |
| Decision Date |
04/13/2012 |
| 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 |
|