Cleared Traditional

K191939 - Yushan X-Ray Flat Panel Detector (FDA 510(k) Clearance)

K191939 · Innocare Optoelectronics Corp. · Radiology device

Aug 2019

Decision

41d

Days

Class 2

Risk

K191939 is an FDA 510(k) clearance for the Yushan X-Ray Flat Panel Detector. 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 August 29, 2019, 41 days after receiving the submission on July 19, 2019.

This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1680.

Submission Details

510(k) Number	K191939 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (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