Device Classification Name |
system, x-ray, fluoroscopic, image-intensified
|
510(k) Number |
K012424 |
Device Name |
SHIMADZU IMAGE AMPLIFIER MODEL # IA-16LM |
Applicant |
SHIMADZU CORP. |
20101 SOUTH VERMONT AVE. |
TORRANCE,
CA
90502 -1328
|
|
Applicant Contact |
MICHAEL FISHBACK |
Correspondent |
SHIMADZU CORP. |
20101 SOUTH VERMONT AVE. |
TORRANCE,
CA
90502 -1328
|
|
Correspondent Contact |
MICHAEL FISHBACK |
Regulation Number | 892.1650
|
Classification Product Code |
|
Date Received | 07/30/2001 |
Decision Date | 10/18/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|