Device Classification Name |
system, planning, radiation therapy treatment
|
510(k) Number |
K141860 |
Device Name |
RAYSTATION |
Applicant |
RAYSEARCH LABORATORIES AB |
SVEAV 25, PLAN 9 |
STOCKHOLM,
SE
111 34
|
|
Applicant Contact |
DAVID HEDFORS |
Correspondent |
RAYSEARCH LABORATORIES AB |
SVEAV 25, PLAN 9 |
STOCKHOLM,
SE
111 34
|
|
Correspondent Contact |
DAVID HEDFORS |
Regulation Number | 892.5050
|
Classification Product Code |
|
Date Received | 07/10/2014 |
Decision Date | 10/23/2014 |
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
|
|
|