Cleared Traditional

Yushan X-Ray Flat Panel Detector with DROC

K201528 · Innocare Optoelectronics Corp. · Radiology
Oct 2020
Decision
125d
Days
Class 2
Risk

About This 510(k) Submission

K201528 is an FDA 510(k) clearance for the Yushan X-Ray Flat Panel Detector with DROC, 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 October 11, 2020, 125 days after receiving the submission on June 8, 2020. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1680.

Submission Details

510(k) Number K201528 FDA.gov
FDA Decision Cleared SESE
Date Received June 08, 2020
Decision Date October 11, 2020
Days to Decision 125 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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