Device Classification Name |
system, x-ray, tomography, computed
|
510(k) Number |
K143294 |
Device Name |
Adaptive Motion Correction (AMC), CSMC-001A and 4D Airways |
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 | 11/17/2014 |
Decision Date | 05/15/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|