Device Classification Name |
System, Nuclear Magnetic Resonance Imaging
|
510(k) Number |
K080038 |
Device Name |
VANTAGE TITAN, MODEL MRT-1504/S3 |
Applicant |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
2441 MICHELLE DR. |
TUSTIN,
CA
92780
|
|
Applicant Contact |
PAUL BIGGINS |
Correspondent |
REGULATORY TECHNOLOGY SERVICES, LLC |
1000 Westgate Drive, |
Suite 510k |
Saint Paul,
MN
55114
|
|
Correspondent Contact |
MARK JOB |
Regulation Number | 892.1000
|
Classification Product Code |
|
Date Received | 01/07/2008 |
Decision Date | 01/22/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|