Cleared Special

K213529 - Focus HD 43 Detector

K213529 is an FDA 510(k) clearance for Focus HD 43 Detector, manufactured by Iray Technology Taicang , Ltd.. The device is a Class 2 Radiology device with product code MQB cleared through the Special 510(k) pathway after a 145-day FDA review.

K213529 · Iray Technology Taicang , Ltd. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2022
Decision
145d
Days
Class 2
Risk

K213529 is an FDA 510(k) clearance for the Focus HD 43 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 March 29, 2022 after a review of 145 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. 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K213529

510(k) Number K213529 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 2021
Decision Date March 29, 2022
Days to Decision 145 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
38d slower than avg
Panel avg: 107d · This submission: 145d
Pathway characteristics
Modification to existing cleared device.

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 K213529.
Digital flat panel detector
K220536 · Iray Technology Taicang , Ltd. · Apr 2022
Yushan X-Ray Flat Panel Detector with DROC
K220510 · Innocare Optoelectronics Corp. · Apr 2022
Wireless Digital Flat Panel Detector
K220668 · Iray Technology Taicang , Ltd. · Apr 2022
Focus HD 35 Detector
K213646 · Iray Technology Taicang , Ltd. · Mar 2022
14HQ901G-B
K214044 · Lg Electronics.Inc · Feb 2022
Digital Radiography CXDI-Pro, Digital Radiography D1
K220098 · Canon, Inc. · Feb 2022
K213529 · Focus HD 43 Detector
Download PDF FDA Summary Iray Technology Taica…