Cleared Traditional

K220510 - Yushan X-Ray Flat Panel Detector with DROC (FDA 510(k) Clearance)

K220510 · Innocare Optoelectronics Corp. · Radiology device

Apr 2022

Decision

51d

Days

Class 2

Risk

K220510 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, 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 FDA review panel. Regulated under 21 CFR 892.1680.

Submission Details

510(k) Number	K220510 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (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