Device Classification Name |
accelerator, linear, medical
|
510(k) Number |
K011763 |
Device Name |
OMNIDOS |
Applicant |
SCANDITRONIX MEDICAL AB |
STALGATAN 14 |
UPPSALA S-754 50,
SE
S-754 50
|
|
Applicant Contact |
ALF OHMAN |
Correspondent |
SCANDITRONIX MEDICAL AB |
STALGATAN 14 |
UPPSALA S-754 50,
SE
S-754 50
|
|
Correspondent Contact |
ALF OHMAN |
Regulation Number | 892.5050
|
Classification Product Code |
|
Date Received | 06/07/2001 |
Decision Date | 09/05/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|