Device Classification Name |
solid state x-ray imager (flat panel/digital imager)
|
510(k) Number |
K070528 |
Device Name |
PHILIPS ESSENTA DR |
Applicant |
PHILIPS MEDICAL SYSTEMS GMBH, DMC |
22100 BOTHELL EVERETT HIGHWAY |
BOTHELL,
WA
98041 -3003
|
|
Applicant Contact |
LYNN HARMER |
Correspondent |
UNDERWRITERS LABORATORIES, INC. |
2600 NW LAKE RD. |
CAMAS,
WA
98607 -9526
|
|
Correspondent Contact |
MARC M MOUSER |
Regulation Number | 892.1680
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 02/23/2007 |
Decision Date | 03/09/2007 |
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
|
|
|