Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

PlutoX Digital Intraoral X-Ray Imaging System

K-Number: K210312 · 2021-04-23

ApplicantIray Technology Taicang , Ltd.
Decision Date2021-04-23
Product CodeMUH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PlutoX Digital Intraoral X-Ray Imaging System is the device name listed in this FDA 510(k) record. The listed applicant is Iray Technology Taicang , Ltd.. It received FDA 510(k) clearance on 2021-04-23 under 510(k) number K210312. The device is classified under product code MUH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PlutoX Digital Intraoral X-Ray Imaging System?

PlutoX Digital Intraoral X-Ray Imaging System is a medical device that received FDA 510(k) clearance on 2021-04-23. The listed applicant is Iray Technology Taicang , Ltd.. The 510(k) number is K210312.

When did PlutoX Digital Intraoral X-Ray Imaging System receive FDA 510(k) clearance?

PlutoX Digital Intraoral X-Ray Imaging System received FDA 510(k) clearance on 2021-04-23, under 510(k) number K210312.

Who is the listed applicant for PlutoX Digital Intraoral X-Ray Imaging System?

The FDA 510(k) record lists Iray Technology Taicang , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PlutoX Digital Intraoral X-Ray Imaging System?

The FDA product code for PlutoX Digital Intraoral X-Ray Imaging System is MUH.

Other records listing Iray Technology Taicang , Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K223010Portable X-ray SystemK222886Mercu 1717VK221714Flat Panel DetectorK221345Wireless Digital Flat Panel DetectorK220536Digital flat panel detectorK220668Wireless Digital Flat Panel Detector

View all 21 devices →

Related Devices (Code: MUH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251793SOTA Cloud Smart Sensor (1.5)Sota Cloud Corp.K252570EzSensor HD, EzSensor UHDQpix Solutions, Inc.K250687Cocoon Solo (DX-7020s)Dexcowin Global, Inc.K251206Digital X-Ray DentiMax Pro Imaging SystemDentimax, Inc.K240040VistaPano S Ceph 2.0 (VistaPano S Ceph); VistaPano S 2.0 (VistaPano S); ProVecta S-Pan Ceph 2.0 (ProVecta S-Pan Ceph); ProVecta S-Pan 2.0 (ProVecta S-Pan)VATECH Co., Ltd.K242778X Sensor (Model: IOS-A15IF, HDI-15DGF)Qpix Solutions, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑