Device Classification Name |
Generator, High-Voltage, X-Ray, Diagnostic
|
510(k) Number |
K945668 |
Device Name |
KXO-80G |
Applicant |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
2441 MICHELLE DR. |
P.O. BOX 2068 |
TUSTIN,
CA
92781 -2068
|
|
Applicant Contact |
JAVAD SEYEDZADEH |
Correspondent |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
2441 MICHELLE DR. |
P.O. BOX 2068 |
TUSTIN,
CA
92781 -2068
|
|
Correspondent Contact |
JAVAD SEYEDZADEH |
Regulation Number | 892.1700
|
Classification Product Code |
|
Date Received | 11/17/1994 |
Decision Date | 12/27/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|