Device Classification Name |
system, x-ray, tomography, computed
|
510(k) Number |
K053148 |
Device Name |
CXR16 |
Applicant |
HITACHI MEDICAL SYSTEMS AMERICA, INC. |
1959 SUMMIT COMMERCE PARK |
TWINSBURG,
OH
44087
|
|
Applicant Contact |
DOUG THISTLETHWAITE |
Correspondent |
INTERTEK TESTING SERVICES |
70 CODMAN HILL RD. |
BOXBOROUGH,
MA
01719
|
|
Correspondent Contact |
NEIL E DEVINE |
Regulation Number | 892.1750
|
Classification Product Code |
|
Date Received | 11/10/2005 |
Decision Date | 02/17/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|