Cleared Traditional

Yushan X-Ray Flat Panel Detector with DROC

K210988 · Innocare Optoelectronics Corp. · Radiology
Apr 2021
Decision
20d
Days
Class 2
Risk

About This 510(k) Submission

K210988 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 April 21, 2021, 20 days after receiving the submission on April 1, 2021. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1680.

Submission Details

510(k) Number K210988 FDA.gov
FDA Decision Cleared SESE
Date Received April 01, 2021
Decision Date April 21, 2021
Days to Decision 20 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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