Device Classification Name |
Accelerator, Linear, Medical
|
510(k) Number |
K092018 |
Device Name |
OMNIPRO INCLINE |
Applicant |
IBA DOSIMETRY GMBH |
3150 STAGE POST DR |
SUITE 110 |
BARTLETT,
TN
38133
|
|
Applicant Contact |
CHUCK LINDLEY |
Correspondent |
IBA DOSIMETRY GMBH |
3150 STAGE POST DR |
SUITE 110 |
BARTLETT,
TN
38133
|
|
Correspondent Contact |
CHUCK LINDLEY |
Regulation Number | 892.5050
|
Classification Product Code |
|
Date Received | 07/06/2009 |
Decision Date | 09/18/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|