D2P

FDA 510(k) K183489 · 3D Systems, Inc.

Substantially Equivalent

510(k) numberK183489

Submission

Device name
D2P
Applicant
3D Systems, Inc.
Airport City, IL
Received
December 17, 2018
Decision date
August 29, 2019
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
LLZ – System, Image Processing, Radiological
Device class
Class II (moderate risk)
Regulation
21 CFR 892.2050
Specialty
Radiology

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Questions and answers

When was D2P cleared by the FDA?

D2P (K183489) received a 510(k) decision of Substantially Equivalent on August 29, 2019, 255 days after the submission was received.

What is the product code of K183489?

The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.