Cleared Special

K210314 - Mars1717X Wireless Digital Flat Panel D...

K210314 is the FDA 510(k) clearance for Mars1717X Wireless Digital Flat Panel D... by Iray Technology Taicang , Ltd.. It is a Class 2 Radiology device (product code MQB) cleared through the Special 510(k) pathway after a 27-day FDA review.

K210314 · Iray Technology Taicang , Ltd. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2021
Decision
27d
Days
Class 2
Risk

K210314 is an FDA 510(k) clearance for the Mars1717X Wireless Digital Flat Panel 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 2, 2021 after a review of 27 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 K210314 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 2021
Decision Date March 02, 2021
Days to Decision 27 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
80d faster than avg
Panel avg: 107d · This submission: 27d
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 218
Devices cleared under the same product code (MQB) and FDA review panel - the closest regulatory comparables to K210314.
I-Q View
K203703 · First Source, Inc. · Mar 2021
ADD
K203188 · H&abyz Co., Ltd. · Mar 2021
Mars 1417X Wireless Digital Flat Panel Detector
K210316 · Iray Technology Taicang , Ltd. · Mar 2021
X-ray Flat Panel Detectors/CareView 3600RF
K202995 · Careray Digital Medical System Co., Ltd. · Feb 2021
General Radiography CXDI-CS01
K203849 · Canon, Inc. · Jan 2021
Lux 35 Detector
K203159 · Carestream Health · Dec 2020