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U.S. Department of Health and Human Services

510(k) Premarket Notification
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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 Hwy.
Bothell,  WA  98041
Applicant Contact LYNN HARMER
Correspondent
Underwriters Laboratories, Inc.
2600 NW Lake Rd.
Camas,  WA  98607
Correspondent Contact MARC M MOUSER
Regulation Number892.1680
Classification Product Code
MQB  
Subsequent Product Code
IZL  
Date Received02/23/2007
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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