Device Classification Name |
System, Image Processing, Radiological
|
510(k) Number |
K023440 |
Device Name |
PHILIPS DIGITAL IMAGING OPTION RELEASE 1 |
Applicant |
PHILIPS MEDICAL SYSTEMS |
22100 BOTHELL EVERETT HWY |
P.O. BOX 3003 |
BOTHELL,
WA
98041 -8431
|
|
Applicant Contact |
LYNN HARMER |
Correspondent |
UNDERWRITERS LABORATORIES, INC. |
1655 SCOTT BLVD. |
SANTA CLARA,
CA
95050
|
|
Correspondent Contact |
MICHAEL KWAN |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 10/15/2002 |
Decision Date | 10/30/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|