Device Classification Name |
System, X-Ray, Tomography, Computed
|
510(k) Number |
K010817 |
Device Name |
MX8000 V5.0 CT SYSTEM |
Applicant |
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. |
595 MINER RD. |
CLEVELAND,
OH
44143
|
|
Applicant Contact |
ROBERT L TUROCY |
Correspondent |
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. |
595 MINER RD. |
CLEVELAND,
OH
44143
|
|
Correspondent Contact |
ROBERT L TUROCY |
Regulation Number | 892.1750
|
Classification Product Code |
|
Date Received | 03/19/2001 |
Decision Date | 06/15/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|