Cleared Traditional

Yushan X-Ray Flat Panel Detector

K191939 · Innocare Optoelectronics Corp. · Radiology
Aug 2019
Decision
41d
Days
Class 2
Risk

About This 510(k) Submission

K191939 is an FDA 510(k) clearance for the Yushan X-Ray Flat Panel Detector, a Solid State X-ray Imager (flat Panel/digital Imager) (Class II — Special Controls, product code MQB), submitted by Innocare Optoelectronics Corp. (Tainan City, TW). The FDA issued a Cleared decision on August 29, 2019, 41 days after receiving the submission on July 19, 2019. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1680.

Submission Details

510(k) Number K191939 FDA.gov
FDA Decision Cleared SESE
Date Received July 19, 2019
Decision Date August 29, 2019
Days to Decision 41 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code MQB — Solid State X-ray Imager (flat Panel/digital Imager)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1680

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