Device Classification Name |
Accelerator, Linear, Medical
|
510(k) Number |
K113276 |
Device Name |
CATALYST |
Applicant |
C-RAD POSITIONING AB |
BREDGRAND 18 |
UPPSALA,
SE
75320
|
|
Applicant Contact |
JANINA OSTLING |
Correspondent |
C-RAD POSITIONING AB |
BREDGRAND 18 |
UPPSALA,
SE
75320
|
|
Correspondent Contact |
JANINA OSTLING |
Regulation Number | 892.5050
|
Classification Product Code |
|
Date Received | 11/07/2011 |
Decision Date | 02/27/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|