Device Classification Name |
system, x-ray, tomography, computed
|
510(k) Number |
K991766 |
Device Name |
ECG-GATING SYSTEM FOR AQUILION CT SCANNER, TSX-101A |
Applicant |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
2441 MICHELLE DR. |
P.O. BOX 2068 |
TUSTIN,
CA
92781 -2068
|
|
Applicant Contact |
PAUL BIGGINS |
Correspondent |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
2441 MICHELLE DR. |
P.O. BOX 2068 |
TUSTIN,
CA
92781 -2068
|
|
Correspondent Contact |
PAUL BIGGINS |
Regulation Number | 892.1750
|
Classification Product Code |
|
Date Received | 05/24/1999 |
Decision Date | 08/10/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|