Yushan X-Ray Flat Panel Detector— 510(k) K243171

Name: FDA 510(k) clearance K243171
Creator: U.S. Food and Drug Administration
Published: 2024-12-19

Substantially Equivalent

Innocare Optoelectronics Corp.

FDA 510(k) clearance K243171 for Yushan X-Ray Flat Panel Detector, Substantially Equivalent on 2024-12-19. 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: 2024-09-30
Decision date: 2024-12-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tainan, TW

Download summary PDF View on FDA.gov ↗

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K191939 — Yushan X-Ray Flat Panel Detector2019-08-29

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