HyperLight Portable X-ray Unit— 510(k) K232068

Name: FDA 510(k) clearance K232068
Creator: U.S. Food and Drug Administration
Published: 2023-09-01

Substantially Equivalent

Changzhou Sifary Medical Technology Co., Ltd.

FDA 510(k) clearance K232068 for HyperLight Portable X-ray Unit, Substantially Equivalent on 2023-09-01. Applicant: Changzhou Sifary Medical Technology Co., Ltd.. Device class: 2.

Clearance details

Applicant: Changzhou Sifary Medical Technology Co., Ltd.
Product code: Code EHD
Device class: Class 2
Regulation: 21 CFR 872.1800
Advisory panel: Dental
Date received: 2023-07-12
Decision date: 2023-09-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Changzhou, CN

Download summary PDF View on FDA.gov ↗

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