Yushan X-Ray Flat Panel Detector with DROC— 510(k) K220510

Name: FDA 510(k) clearance K220510
Creator: U.S. Food and Drug Administration
Published: 2022-04-14

Substantially Equivalent

Innocare Optoelectronics Corp.

FDA 510(k) clearance K220510 for Yushan X-Ray Flat Panel Detector with DROC, Substantially Equivalent on 2022-04-14. Applicant: Innocare Optoelectronics Corp.. Device class: 2.

Clearance details

Applicant: Innocare Optoelectronics Corp.
Product code: Code MQB
Device class: Class 2
Regulation: 21 CFR 892.1680
Advisory panel: Radiology
Date received: 2022-02-22
Decision date: 2022-04-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tainan, TW

Download summary PDF View on FDA.gov ↗

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