Cleared Special

K200622 - Focus 43C detector

K200622 is the FDA 510(k) clearance for Focus 43C detector by Iray Technology Taicang , Ltd.. It is a Class 2 Radiology device (product code MQB) cleared through the Special 510(k) pathway after a 23-day FDA review.

K200622 · Iray Technology Taicang , Ltd. · Radiology device
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Apr 2020
Decision
23d
Days
Class 2
Risk

K200622 is an FDA 510(k) clearance for the Focus 43C detector, TRIMAX 43C detector. Classified as Solid State X-ray Imager (flat Panel/digital Imager) (product code MQB), Class II - Special Controls.

Submitted by Iray Technology Taicang , Ltd. (Taicang, CN). The FDA issued a Cleared decision on April 1, 2020 after a review of 23 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1680 - the FDA radiology and imaging software oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Iray Technology Taicang , Ltd. devices

Submission Details

510(k) Number K200622 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 2020
Decision Date April 01, 2020
Days to Decision 23 days
Submission Type Special
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
84d faster than avg
Panel avg: 107d · This submission: 23d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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.

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