Device Classification Name |
system, x-ray, tomography, computed
|
510(k) Number |
K071806 |
Device Name |
ECLOS COMPUTED TOMOGRAPHY X-RAY SYSTEM |
Applicant |
HITACHI MEDICAL SYSTEMS AMERICA, INC. |
1959 SUMMIT COMMERCE PARK |
TWINSBURG,
OH
44087
|
|
Applicant Contact |
DOUGLAS THISTLETHWAITE |
Correspondent |
HITACHI MEDICAL SYSTEMS AMERICA, INC. |
1959 SUMMIT COMMERCE PARK |
TWINSBURG,
OH
44087
|
|
Correspondent Contact |
DOUGLAS THISTLETHWAITE |
Regulation Number | 892.1750
|
Classification Product Code |
|
Date Received | 07/02/2007 |
Decision Date | 08/28/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|