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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 K131483
Device Name PHILIPS PIXIUM 4343RC
Applicant
Philips Medical Systems Dmc GmbH
409 Woodridge Dr.
Seneca,  SC  29672
Applicant Contact JENNIFER CARTLEDGE
Correspondent
Philips Medical Systems Dmc GmbH
409 Woodridge Dr.
Seneca,  SC  29672
Correspondent Contact JENNIFER CARTLEDGE
Regulation Number892.1680
Classification Product Code
MQB  
Date Received05/23/2013
Decision Date 10/07/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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