DigitalDiagnost C90

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 Digitaldiagnost C90.

Pre-market Notification Details

Device IDK202564
510k NumberK202564
Device Name:DigitalDiagnost C90
ClassificationSolid State X-ray Imager (flat Panel/digital Imager)
Applicant Philips Medical Systems DMC GmbH Röntgenstraße 24 Hamburg,  DE 22335
ContactMing Xiao
CorrespondentPrithul Bom
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeMQB  
Subsequent Product CodeKPR
Subsequent Product CodeLLZ
CFR Regulation Number892.1680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedYes
Combination ProductNo
Date Received2020-09-04
Decision Date2020-09-30

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