Cleared Traditional

K201528 - Yushan X-Ray Flat Panel Detector with DROC

K201528 is an FDA 510(k) clearance for Yushan X-Ray Flat Panel Detector with DROC, manufactured by Innocare Optoelectronics Corp.. The device is a Class 2 Radiology device with product code MQB cleared through the Traditional 510(k) pathway after a 125-day FDA review.

K201528 · Innocare Optoelectronics Corp. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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. Classified as Solid State X-ray Imager (flat Panel/digital Imager) (product code MQB), Class II - Special Controls.

Submitted by Innocare Optoelectronics Corp. (Tainan City, TW). The FDA issued a Cleared decision on October 11, 2020 after a review of 125 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1680 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Innocare Optoelectronics Corp. devices

FDA 510(k) Submission Details - K201528

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
18d slower than avg
Panel avg: 107d · This submission: 125d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MQB Device Classification - Class 2, Special Controls

Product Code MQB Solid State X-ray Imager (flat Panel/digital Imager)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1680
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - MQB Solid State X-ray Imager (flat Panel/digital Imager)

All 259
Devices cleared under the same product code (MQB) and FDA review panel - the closest regulatory comparables to K201528.
General Radiography CXDI-CS01
K203849 · Canon, Inc. · Jan 2021
Lux 35 Detector
K203159 · Carestream Health · Dec 2020
1212FCA
K202722 · Rayence Co., Ltd. · Oct 2020
DigitalDiagnost C90
K202564 · Philips Medical Systems Dmc GmbH · Sep 2020
Flat Panel Detector
K201591 · Ka Imaging, Inc. · Sep 2020
X-ray Flat Panel Detectors (CareView 1800Cwe /CareView 1500Cwe)
K201932 · Careray Digital Medical System Co., Ltd. · Aug 2020