Device Classification Name |
Collimator, Manual, Radiographic
|
510(k) Number |
K101036 |
Device Name |
SHIMADZU COLLIMATOR R-20J |
Applicant |
SHIMADZU CORP. |
20101 SOUTH VERMONT AVE. |
TORRANCE,
CA
90502 -1328
|
|
Applicant Contact |
DONALD KARLE |
Correspondent |
SHIMADZU CORP. |
20101 SOUTH VERMONT AVE. |
TORRANCE,
CA
90502 -1328
|
|
Correspondent Contact |
DONALD KARLE |
Regulation Number | 892.1610
|
Classification Product Code |
|
Date Received | 04/14/2010 |
Decision Date | 08/26/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Statement |
Statement
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|