D2P

System, Image Processing, Radiological

3D SYSTEMS, INC.

The following data is part of a premarket notification filed by 3d Systems, Inc. with the FDA for D2p.

Pre-market Notification Details

Device IDK161841
510k NumberK161841
Device Name:D2P
ClassificationSystem, Image Processing, Radiological
Applicant 3D SYSTEMS, INC. CORNER OF GOLAN AND HANEGEV STREET Airport City,  IL 70151
ContactKim Torluemke
CorrespondentKim Torluemke
3D SYSTEMS, INC. 5381 SOUTH ALKIRE CIRCLE Littleton,  CO  80127
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-07-05
Decision Date2017-01-09
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00816847021470 K161841 000
00816847022569 K161841 000

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