Cleared Traditional

K210312 - PlutoX Digital Intraoral X-Ray Imaging ...

K210312 is the FDA 510(k) clearance for PlutoX Digital Intraoral X-Ray Imaging ... by Iray Technology Taicang , Ltd.. It is a Class 2 Radiology device (product code MUH) cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K210312 · Iray Technology Taicang , Ltd. · Radiology device
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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 71
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