Device Classification Name |
System, Planning, Radiation Therapy Treatment
|
510(k) Number |
K100552 |
Device Name |
RAYSTATION VERSION 1.0 |
Applicant |
RAYSEARCH LABORATORIES AB |
SVEAVAGEN 25, PLAN 9 |
STOCKHOLM,
SE
SE-111 34
|
|
Applicant Contact |
ANDERS MURMAN |
Correspondent |
UNDERWRITERS LABORATORIES, INC. |
1285 WALT WHITMAN RD. |
MELVILLE,
NY
11747
|
|
Correspondent Contact |
CASEY CONRY |
Regulation Number | 892.5050
|
Classification Product Code |
|
Date Received | 02/26/2010 |
Decision Date | 03/12/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|