Cleared Traditional

K162909 - CSX-30 Flat Panel Detector

K162909 is an FDA 510(k) clearance for CSX-30 Flat Panel Detector, manufactured by Canon Inc. -Medical Equipment Group. The device is a Class 2 Radiology device with product code MQB cleared through the Traditional 510(k) pathway after a 102-day FDA review.

K162909 · Canon Inc. -Medical Equipment Group · Radiology device
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Jan 2017
Decision
102d
Days
Class 2
Risk

K162909 is an FDA 510(k) clearance for the CSX-30 Flat Panel Detector. Classified as Solid State X-ray Imager (flat Panel/digital Imager) (product code MQB), Class II - Special Controls.

Submitted by Canon Inc. -Medical Equipment Group (Kawasaki, JP). The FDA issued a Cleared decision on January 27, 2017 after a review of 102 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 Canon Inc. -Medical Equipment Group devices

FDA 510(k) Submission Details - K162909

510(k) Number K162909 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 2016
Decision Date January 27, 2017
Days to Decision 102 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
5d faster than avg
Panel avg: 107d · This submission: 102d
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 260
Devices cleared under the same product code (MQB) and FDA review panel - the closest regulatory comparables to K162909.
1717SCC_127um and 1717SCC_140um
K171420 · Rayence Co., Ltd. · Jun 2017
EVS 2430W, EVS 2430GW
K171137 · DRTECH Corporation · May 2017
DIGITAL RADIOGRAPHY CXDI-710C WIRELESS, DIGITAL RADIOGRAPHY CXDI-810C WIRELESS
K170332 · Canon, Inc. · Mar 2017
EVS 4343, EVS 4343G
K162555 · DRTECH Corporation · Dec 2016
EVS 3643, EVS 3643G
K162552 · DRTECH Corporation · Dec 2016
1012WCC, 1012WGC
K162518 · Rayence Co., Ltd. · Oct 2016