Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name System, Image Processing, Radiological
510(k) Number K183489
Device Name D2P
Applicant
3D Systems, Inc.
Corner of Golan and Hanegev Street
Airport City,  IL 70151
Applicant Contact Kim Torluemke
Correspondent
3D Systems, Inc.
5381 South Alkire Circle
Littleton,  CO  80127
Correspondent Contact Kim Torluemke
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received12/17/2018
Decision Date 08/29/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-