EzOrtho

FDA 510(k) K202948 · Ewoosoft Co., Ltd.

Substantially Equivalent

510(k) numberK202948

Submission

Device name
EzOrtho
Applicant
Ewoosoft Co., Ltd.
Hwaseong-Si, KR
Received
September 30, 2020
Decision date
October 22, 2020
Decision
Substantially Equivalent (SESE)
Type
Special 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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More from Avara Software

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K241114EzDent-i / E2 / Prora View / Smart M Viewer (v3.5)LLZ · Special 07/23/2024SE
K231757Ez3D-i /E3QIH · Special 07/14/2023SE
K230468EzDent WebLLZ · Traditional 04/21/2023SE
K223820EzDent-i / E2 / Prora View/ Smart M ViewerLLZ · Traditional 02/17/2023SE
K222069Ez3D-i/E3LLZ · Traditional 09/06/2022SE
K222145EzDent-i / E2 / Prora View/ Smart M ViewerLLZ · Traditional 08/12/2022SE
K220003EzOrtho v1.3LLZ · Traditional 02/23/2022SE
K211795EzDent-i/ E2/ Prora View/ Smart M ViewerLLZ · Traditional 10/04/2021SE
K211700EzDent WebLLZ · Traditional 09/28/2021SE

Questions and answers

When was EzOrtho cleared by the FDA?

EzOrtho (K202948) received a 510(k) decision of Substantially Equivalent on October 22, 2020, 22 days after the submission was received.

What is the product code of K202948?

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