Device Classification Name |
system, image processing, radiological
|
510(k) Number |
K003437 |
Device Name |
ODYSSEY LX, MODEL 211320 |
Applicant |
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. |
595 MINER RD. |
CLEVELAND,
OH
44143
|
|
Applicant Contact |
RONALD J MARTONE |
Correspondent |
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. |
595 MINER RD. |
CLEVELAND,
OH
44143
|
|
Correspondent Contact |
RONALD J MARTONE |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 11/06/2000 |
Decision Date | 02/02/2001 |
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
|
|
|