Device Classification Name |
System, Planning, Radiation Therapy Treatment
|
510(k) Number |
K090808 |
Device Name |
PINNACLE3 SMARTARC |
Applicant |
PHILIPS MEDICAL SYSTEMS, INC. |
5520 NOBEL DR. |
SUITE 125 |
FITCHBURG,
WI
53711
|
|
Applicant Contact |
JILL KAEDER |
Correspondent |
UNDERWRITERS LABORATORIES, INC. |
1285 WALT WHITMAN RD. |
MELVILLE,
NY
11747
|
|
Correspondent Contact |
CASEY CONRY |
Regulation Number | 892.5050
|
Classification Product Code |
|
Date Received | 03/25/2009 |
Decision Date | 04/03/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|