Cleared Traditional

K162344 - INNOLUX RIC

K162344 is an FDA 510(k) clearance for INNOLUX RIC, manufactured by Innolux Corporation. The device is a Class 2 Radiology device with product code MQB cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K162344 · Innolux Corporation · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2016
Decision
120d
Days
Class 2
Risk

K162344 is an FDA 510(k) clearance for the INNOLUX RIC. Classified as Solid State X-ray Imager (flat Panel/digital Imager) (product code MQB), Class II - Special Controls.

Submitted by Innolux Corporation (Tainan City, Southern Taiwan Science Par, TW). The FDA issued a Cleared decision on December 20, 2016 after a review of 120 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.

FDA 510(k) Submission Details - K162344

510(k) Number K162344 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 22, 2016
Decision Date December 20, 2016
Days to Decision 120 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
13d slower than avg
Panel avg: 107d · This submission: 120d
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 423
Devices cleared under the same product code (MQB) and FDA review panel - the closest regulatory comparables to K162344.
VIVIX-S 1417N
K163703 · Vieworks Co., Ltd. · Feb 2017
CSX-30 Flat Panel Detector
K162909 · Canon Inc. -Medical Equipment Group · Jan 2017
EVS 4343, EVS 4343G
K162555 · DRTECH Corporation · Dec 2016
Wireless Digital Flat Panel Detector
K161730 · Iray Technology (Shanghai) , Ltd. · Dec 2016
EVS 3643, EVS 3643G
K162552 · DRTECH Corporation · Dec 2016
CareView 750Cw/750C X-ray Flat Panel Detectors
K163019 · Careray Digital Medical System Co., Ltd. · Dec 2016
K162344 · INNOLUX RIC
Download PDF FDA Summary Innolux Corporation