Ez3D-i /E3— 510(k) K231757

Substantially Equivalent

Ewoosoft Co., Ltd.

FDA 510(k) clearance K231757 for Ez3D-i /E3, Substantially Equivalent on 2023-07-14. Applicant: Ewoosoft Co., Ltd.. Device class: 2.

Clearance details

Applicant: Ewoosoft Co., Ltd.
Product code: Code QIH
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2023-06-16
Decision date: 2023-07-14
Decision: Substantially Equivalent
Clearance type: Special
Location: Hwaseong-Si, KR

Download summary PDF View on FDA.gov ↗

Recent devices under product code QIH

K260879 — 4DM2026-09-10
K261795 — Quicktome Software Suite2026-09-10
K251417 — ReVISION 22026-09-09
K260525 — NextMR Spine2026-09-04
K260811 — Heartvue.Proton2026-08-26

More clearances from Ewoosoft Co., Ltd.

K250005 — Clever One2025-05-23
K241114 — EzDent-i / E2 / Prora View / Smart M Viewer (v3.5)2024-07-23
K230468 — EzDent Web2023-04-21
K223820 — EzDent-i / E2 / Prora View/ Smart M Viewer2023-02-17
K222069 — Ez3D-i/E32022-09-06

Data sourced from openFDA. This site is unofficial and independent of the FDA.