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
Combination Product No
PCCP Authorized No
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 Consultant

Ken Block Consulting
Diane Rutherford

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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

All 422
Devices cleared under the same product code (MQB) and FDA review panel - the closest regulatory comparables to K162909.
Aquarius 8600
K170202 · Imaging Dynamics Company , Ltd. · Feb 2017
pixium 4343RCE
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VIVIX-S 1417N
K163703 · Vieworks Co., Ltd. · Feb 2017
EVS 4343, EVS 4343G
K162555 · DRTECH Corporation · Dec 2016
INNOLUX RIC
K162344 · Innolux Corporation · Dec 2016
Wireless Digital Flat Panel Detector
K161730 · Iray Technology (Shanghai) , Ltd. · Dec 2016