Device Classification Name |
System, X-Ray, Tomography, Computed
|
510(k) Number |
K161009 |
Device Name |
Aquilion ONE Vision with FIRST 2.0 (CCRS-001B) V7.4 |
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 |
Regulation Number | 892.1750
|
Classification Product Code |
|
Date Received | 04/11/2016 |
Decision Date | 07/22/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|