Device Classification Name |
System, X-Ray, Tomography, Computed
|
510(k) Number |
K113483 |
Device Name |
ITERATIVE RECONSTRUCTION TECHNIQUE SOFTWARE APPLICATION |
Applicant |
PHILIPS HEALTHCARE (CLEVELAND) |
595 MINER RD. |
CLEVELAND,
OH
44143
|
|
Applicant Contact |
CHRISTINE ANDERSON |
Correspondent |
PHILIPS HEALTHCARE (CLEVELAND) |
595 MINER RD. |
CLEVELAND,
OH
44143
|
|
Correspondent Contact |
CHRISTINE ANDERSON |
Regulation Number | 892.1750
|
Classification Product Code |
|
Date Received | 11/23/2011 |
Decision Date | 09/26/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|