X-MIND prime (under trade mark Acteon), I-MAX (under trade mark Owandy Radiology)— 510(k) K203374

Name: FDA 510(k) clearance K203374
Creator: U.S. Food and Drug Administration
Published: 2021-02-05

Substantially Equivalent

De Götzen S.R.L.

FDA 510(k) clearance K203374 for X-MIND prime (under trade mark Acteon), I-MAX (under trade mark Owandy Radiology), Substantially Equivalent on 2021-02-05. Applicant: De Götzen S.R.L.. Device class: 2.

Clearance details

Applicant: De Götzen S.R.L.
Product code: Code MUH
Device class: Class 2
Regulation: 21 CFR 872.1800
Advisory panel: Dental
Date received: 2020-11-16
Decision date: 2021-02-05
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Olgiate Olona, IT

Download summary PDF View on FDA.gov ↗

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