PlutoX Digital Intraoral X-Ray Imaging System— 510(k) K210312

Name: FDA 510(k) clearance K210312
Creator: U.S. Food and Drug Administration
Published: 2021-04-23

Substantially Equivalent

Iray Technology Taicang , Ltd.

FDA 510(k) clearance K210312 for PlutoX Digital Intraoral X-Ray Imaging System, Substantially Equivalent on 2021-04-23. Applicant: Iray Technology Taicang , Ltd.. Device class: 2.

Clearance details

Applicant: Iray Technology Taicang , Ltd.
Product code: Code MUH
Device class: Class 2
Regulation: 21 CFR 872.1800
Advisory panel: Dental
Date received: 2021-02-03
Decision date: 2021-04-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taicang, CN

Download summary PDF View on FDA.gov ↗

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