Device Classification Name |
Couch, Radiation Therapy, Powered
|
510(k) Number |
K122413 |
FOIA Releasable 510(k) |
K122413
|
Device Name |
PATIENT POSITIONING SYSTEM |
Applicant |
FORTE AUTOMATION SYSTEMS, INC. |
8155 Burden Rd |
Machesney Park,
IL
61115
|
|
Applicant Contact |
PHIL REECE |
Correspondent |
FORTE AUTOMATION SYSTEMS, INC. |
8155 Burden Rd |
Machesney Park,
IL
61115
|
|
Correspondent Contact |
PHIL REECE |
Regulation Number | 892.5770
|
Classification Product Code |
|
Date Received | 08/08/2012 |
Decision Date | 09/13/2012 |
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
|
|
|