Device Classification Name |
System, X-Ray, Tomography, Computed
|
510(k) Number |
K132222 |
Device Name |
AQUILION ONE VISION, V6.0 |
Applicant |
TOSHIBA MEDICAL SYSTEMS CORPORATION |
2441 MICHELLE DRIVE |
TUSTIN,
CA
92780
|
|
Applicant Contact |
PAUL BIGGINS |
Correspondent |
TOSHIBA MEDICAL SYSTEMS CORPORATION |
2441 MICHELLE DRIVE |
TUSTIN,
CA
92780
|
|
Correspondent Contact |
PAUL BIGGINS |
Regulation Number | 892.1750
|
Classification Product Code |
|
Date Received | 07/17/2013 |
Decision Date | 11/07/2013 |
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
|
|
|