Device Classification Name |
System, X-Ray, Tomography, Computed
|
510(k) Number |
K031469 |
Device Name |
AQUILION SUPER 4 MULTISLICE CT SCANNER, MODEL TSX-101A/7 |
Applicant |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
2441 MICHELLE DR. |
P.O. BOX 2068 |
TUSTIN,
CA
92781 -2068
|
|
Applicant Contact |
PAUL BIGGINS |
Correspondent |
TUV AMERICA, INC. |
1775 OLD HIGHWAY 8 |
NEW BRIGHTON,
MN
55112 -1891
|
|
Regulation Number | 892.1750
|
Classification Product Code |
|
Date Received | 05/09/2003 |
Decision Date | 05/22/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|