WillCeph— 510(k) K172168

Name: FDA 510(k) clearance K172168
Creator: U.S. Food and Drug Administration
Published: 2018-03-21

Substantially Equivalent

Hdx Will Corp.

FDA 510(k) clearance K172168 for WillCeph, Substantially Equivalent on 2018-03-21. Applicant: Hdx Will Corp.. Device class: 2.

Clearance details

Applicant: Hdx Will Corp.
Product code: Code LLZ
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2017-07-18
Decision date: 2018-03-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cheongju-Si, KR

Download summary PDF View on FDA.gov ↗

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K192700 — Xcam2019-12-27
K190357 — Star-X, Intraoral X-ray System2019-03-15

Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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