Device Classification Name |
System, Planning, Radiation Therapy Treatment
|
510(k) Number |
K091179 |
Device Name |
MONACO RTP SYSTEM, VMAT OPTION |
Applicant |
COMPUTERIZED MEDICAL SYSTEMS, INC. |
13723 RIVERPORT DR |
SUITE 100 |
MARYLAND HEIGHTS,
MO
63043
|
|
Applicant Contact |
KATHRYN STINSON |
Correspondent |
COMPUTERIZED MEDICAL SYSTEMS, INC. |
13723 RIVERPORT DR |
SUITE 100 |
MARYLAND HEIGHTS,
MO
63043
|
|
Correspondent Contact |
KATHRYN STINSON |
Regulation Number | 892.5050
|
Classification Product Code |
|
Date Received | 04/23/2009 |
Decision Date | 07/16/2009 |
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
|
|
|