PHILIPS PIXIUM 4343RC

Solid State X-ray Imager (flat Panel/digital Imager)

PHILIPS MEDICAL SYSTEMS DMC GMBH

The following data is part of a premarket notification filed by Philips Medical Systems Dmc Gmbh with the FDA for Philips Pixium 4343rc.

Pre-market Notification Details

Device IDK131483
510k NumberK131483
Device Name:PHILIPS PIXIUM 4343RC
ClassificationSolid State X-ray Imager (flat Panel/digital Imager)
Applicant PHILIPS MEDICAL SYSTEMS DMC GMBH 409 WOODRIDGE DR. Seneca,  SC  29672
ContactJennifer Cartledge
CorrespondentJennifer Cartledge
PHILIPS MEDICAL SYSTEMS DMC GMBH 409 WOODRIDGE DR. Seneca,  SC  29672
Product CodeMQB  
CFR Regulation Number892.1680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-05-23
Decision Date2013-10-07
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00884838074279 K131483 000

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