Device Classification Name |
System, X-Ray, Tomography, Computed
|
510(k) Number |
K170019 |
Device Name |
Aquilion Lightning, TSX-036A/1, V8.4 |
Applicant |
Toshiba Medical Systems Corporation |
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 Jr. |
Regulation Number | 892.1750
|
Classification Product Code |
|
Date Received | 01/03/2017 |
Decision Date | 02/02/2017 |
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
|
|
|