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PlutoX Digital Intraoral X-Ray Imaging System

by Iray Technology Taicang, Ltd.

510(k) K210312

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK210312 Date23 Apr 2021ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
MUH
FDA applicant
Iray Technology Taicang , Ltd.
Device Class
Class II
Regulation
21 CFR Part 872.1800
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The PlutoX Digital Intraoral X-Ray Imaging System is a digital X-ray imaging system designed to convert X-ray radiation into digital images. It utilizes a CMOS sensor with a directly deposited CsI:Tl scintillator to convert radiation into visible photons and subsequently into electron signals via a diode capacitor array.

This device features a direct USB interface for connection to a PC and is intended for use in dental imaging applications. It has received FDA 510(k) clearance under K210312. The system is compatible with the Pluto 0000X, Pluto 0001X, Pluto 0015X, and Pluto 0002X sensors.

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Questions

AI-generated answers, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the primary function of the PlutoX Digital Intraoral X-Ray Imaging System?

    The system is designed for dental imaging applications. It functions by converting X-ray radiation into digital images through a CMOS sensor that utilizes a directly deposited CsI:Tl scintillator to capture and process electron signals.

  • How does the PlutoX system connect to a computer?

    The device features a direct USB interface, which allows it to connect directly to a PC for the purpose of digital image acquisition and processing.

  • Which sensors are compatible with this imaging system?

    The PlutoX Digital Intraoral X-Ray Imaging System is compatible with four specific sensor models: Pluto 0000X, Pluto 0001X, Pluto 0015X, and Pluto 0002X.

  • Has this device received regulatory authorization?

    Yes, the PlutoX Digital Intraoral X-Ray Imaging System has received FDA 510(k) clearance under the submission number K210312.