Device Classification Name |
system, imaging, pulsed doppler, ultrasonic
|
510(k) Number |
K981397 |
Device Name |
HARMONIC IMAGING AND FLASH ECHO IMAGING FUNCTION FOR THE DIAGNOSTIC ULTRASOUND SYSTEM SSA-380A, POWERVISION 7000 |
Applicant |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
2441 MICHELLE DR. |
P.O. BOX 2068 |
TUSTIN,
CA
92781 -2068
|
|
Applicant Contact |
PAUL BIGGINS |
Correspondent |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
2441 MICHELLE DR. |
P.O. BOX 2068 |
TUSTIN,
CA
92781 -2068
|
|
Correspondent Contact |
PAUL BIGGINS |
Regulation Number | 892.1550
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 04/17/1998 |
Decision Date | 07/31/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|