Ez3D Plus
FDA 510(k) K152746 · Ewoosoft Co., Ltd.
510(k) numberK152746
Submission
- Device name
- Ez3D Plus
- Applicant
- Ewoosoft Co., Ltd.
Hwaseong-Si, KR - Received
- September 23, 2015
- Decision date
- January 3, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Ez3D Plus cleared by the FDA?
Ez3D Plus (K152746) received a 510(k) decision of Substantially Equivalent on January 3, 2016, 102 days after the submission was received.
What is the product code of K152746?
The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.