Cleared Traditional

K210312 - PlutoX Digital Intraoral X-Ray Imaging System (FDA 510(k) Clearance)

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K210312 · Iray Technology Taicang , Ltd. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2021
Decision
79d
Days
Class 2
Risk

K210312 is an FDA 510(k) clearance for the PlutoX Digital Intraoral X-Ray Imaging System. Classified as System, X-ray, Extraoral Source, Digital (product code MUH), Class II - Special Controls.

Submitted by Iray Technology Taicang , Ltd. (Taicang, CN). The FDA issued a Cleared decision on April 23, 2021 after a review of 79 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 872.1800 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Iray Technology Taicang , Ltd. devices

Submission Details

510(k) Number K210312 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 2021
Decision Date April 23, 2021
Days to Decision 79 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
28d faster than avg
Panel avg: 107d · This submission: 79d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MUH System, X-ray, Extraoral Source, Digital
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.1800
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 - MUH System, X-ray, Extraoral Source, Digital

All 205
Devices cleared under the same product code (MUH) and FDA review panel - the closest regulatory comparables to K210312.
SOTA Cloud Smart Sensor (1.5)
K251793 · Sota Cloud Corp. · Mar 2026
EzSensor HD, EzSensor UHD
K252570 · Qpix Solutions, Inc. · Nov 2025
Cocoon Solo (DX-7020s)
K250687 · Dexcowin Global, Inc. · Oct 2025
Digital X-Ray DentiMax Pro Imaging System
K251206 · Dentimax, Inc. · Sep 2025
VistaPano S Ceph 2.0 (VistaPano S Ceph)
K240040 · VATECH Co., Ltd. · Oct 2024
X Sensor (Model: IOS-A15IF, HDI-15DGF)
K242778 · Qpix Solutions, Inc. · Oct 2024