D2P
FDA 510(k) K161841 · 3D Systems, Inc.
510(k) numberK161841
Submission
- Device name
- D2P
- Applicant
- 3D Systems, Inc.
Airport City, IL - Received
- July 5, 2016
- Decision date
- January 9, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was D2P cleared by the FDA?
D2P (K161841) received a 510(k) decision of Substantially Equivalent on January 9, 2017, 188 days after the submission was received.
What is the product code of K161841?
The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.