Cleared Special

Digital Flat Panel Detector (K230059) - FDA 510(k) Clearance

Class II Radiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K230059 · Ray Imaging Technology (Haining) Limited · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2023
Decision
25d
Days
Class 2
Risk

K230059 is an FDA 510(k) clearance for the Digital Flat Panel Detector. Classified as Solid State X-ray Imager (flat Panel/digital Imager) (product code MQB), Class II - Special Controls.

Submitted by Ray Imaging Technology (Haining) Limited (Haining, CN). The FDA issued a Cleared decision on February 3, 2023 after a review of 25 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 Ray Imaging Technology (Haining) Limited devices

Submission Details

510(k) Number K230059 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 09, 2023
Decision Date February 03, 2023
Days to Decision 25 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
82d faster than avg
Panel avg: 107d · This submission: 25d
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.

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

All 149
Devices cleared under the same product code (MQB) and FDA review panel - the closest regulatory comparables to K230059.
1417WCE, 1417WCE-HR, 1417WCE-HS, 1417WCE-GF
K231467 · Rayence Co., Ltd. · Jun 2023
A1417MCW/A1717MCW/F1417MCW
K223930 · H&abyz Co., Ltd. · Mar 2023
Digital Radiography CXDI-CS01
K230175 · Canon, Inc. · Feb 2023
14HQ721G-B
K223546 · Lg Electronics.Inc · Jan 2023
X-ray Flat Panel Detectors (EverestView 4343X)
K223687 · Careray Digital Medical Technology Co., Ltd. · Dec 2022
Wireless/Wired X-Ray Flat Panel Detectors
K223009 · Allengers Medical Systems Limited · Nov 2022