Device Classification Name |
system, x-ray, tomography, computed
|
510(k) Number |
K040902 |
Device Name |
HITACHI PRESTO |
Applicant |
HITACHI MEDICAL SYSTEMS AMERICA, INC. |
1959 SUMMIT COMMERCE PARK |
TWINSBURG,
OH
44087
|
|
Applicant Contact |
DOUGLAS THISTLETHWAITE |
Correspondent |
INTERTEK TESTING SERVICES |
2307 EAST AURORA ROAD |
UNIT B7 |
TWINSBURG,
OH
44087
|
|
Correspondent Contact |
DERWYN REUBER |
Regulation Number | 892.1750
|
Classification Product Code |
|
Date Received | 04/07/2004 |
Decision Date | 04/21/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|