Device Classification Name |
system, image processing, radiological
|
510(k) Number |
K021314 |
Device Name |
SCEPTRE-VS |
Applicant |
HITACHI MEDICAL SYSTEMS AMERICA, INC. |
1959 SUMMIT COMMERCE PARK |
TWINSBURG,
OH
44087
|
|
Applicant Contact |
ROBERT H MCCARTHY |
Correspondent |
HITACHI MEDICAL SYSTEMS AMERICA, INC. |
1959 SUMMIT COMMERCE PARK |
TWINSBURG,
OH
44087
|
|
Correspondent Contact |
ROBERT H MCCARTHY |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 04/25/2002 |
Decision Date | 07/02/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|