Device Classification Name |
system, x-ray, tomography, computed
|
510(k) Number |
K172188 |
Device Name |
Aquilion Prime SP, TSX-303B/1, v8.4 |
Applicant |
Toshiba Medical Systems Coroporation |
1385 Shimoishigami |
Otawara-shi,
JP
324-8550
|
|
Applicant Contact |
Paul Biggins |
Correspondent |
Toshiba America Medical Systems, Inc. |
2441 Michelle Drive |
Tustin,
CA
92780
|
|
Correspondent Contact |
Orlando Tadeo |
Regulation Number | 892.1750
|
Classification Product Code |
|
Date Received | 07/20/2017 |
Decision Date | 10/06/2017 |
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
|
|
|