Device Classification Name |
System, Nuclear Magnetic Resonance Imaging
|
510(k) Number |
K150427 |
Device Name |
Vantage Titan 1.5T, V3.1, MRT-1510 |
Applicant |
TOSHIBA MEDICAL SYSTEMS CORPORATION |
1385 SHIMOISHIGAMI |
OTAWARA,
JP
324-8550
|
|
Applicant Contact |
Janine Reyes |
Correspondent |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
2441 MICHELLE DRIVE |
TUSTIN,
CA
92780
|
|
Correspondent Contact |
PAUL BIGGINS |
Regulation Number | 892.1000
|
Classification Product Code |
|
Date Received | 02/19/2015 |
Decision Date | 04/17/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|