Device Classification Name |
System, Planning, Radiation Therapy Treatment
|
510(k) Number |
K200569 |
Device Name |
RayStation |
Applicant |
RaySearch Laboratories AB (publ) |
Sveavägen 44 |
Stockholm,
SE
11134
|
|
Applicant Contact |
Viktoria Hammarstedt |
Correspondent |
RaySearch Laboratories AB (publ) |
Sveavägen 44 |
Stockholm,
SE
11134
|
|
Correspondent Contact |
Viktoria Hammarstedt |
Regulation Number | 892.5050
|
Classification Product Code |
|
Date Received | 03/04/2020 |
Decision Date | 09/24/2020 |
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
|
|
|