Cleared Traditional

K201528 - Yushan X-Ray Flat Panel Detector with DROC (FDA 510(k) Clearance)

K201528 · Innocare Optoelectronics Corp. · Radiology device

Oct 2020

Decision

125d

Days

Class 2

Risk

K201528 is an FDA 510(k) clearance for the Yushan X-Ray Flat Panel Detector with DROC. This device is classified as 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 FDA review panel. Regulated under 21 CFR 892.1680.

Submission Details

510(k) Number	K201528 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (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