Device Classification Name |
System, X-Ray, Tomography, Computed
|
510(k) Number |
K150595 |
Device Name |
SCENARIA Phase 3 Whole-body X-ray CT System |
Applicant |
HITACHI MEDICAL SYSTEMS AMERICA, INC. |
1959 SUMMIT COMMERCE PARK |
TWINSBURG,
OH
44087
|
|
Applicant Contact |
Doug Thistlethwaite |
Correspondent |
HITACHI MEDICAL SYSTEMS AMERICA, INC. |
1959 SUMMIT COMMERCE PARK |
TWINSBURG,
OH
44087
|
|
Correspondent Contact |
Doug Thistlethwaite |
Regulation Number | 892.1750
|
Classification Product Code |
|
Date Received | 03/09/2015 |
Decision Date | 10/30/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|