Cleared Traditional

Yushan X-Ray Flat Panel Detector with DROC

K220510 · Innocare Optoelectronics Corp. · Radiology
Apr 2022
Decision
51d
Days
Class 2
Risk

About This 510(k) Submission

K220510 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, TW). The FDA issued a Cleared decision on April 14, 2022, 51 days after receiving the submission on February 22, 2022. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1680.

Submission Details

510(k) Number K220510 FDA.gov
FDA Decision Cleared SESE
Date Received February 22, 2022
Decision Date April 14, 2022
Days to Decision 51 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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