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FDA 510(k)

QuickRayPRO

K-Number: K231202 · 2023-06-22

ApplicantDenterprise International, Inc.
Decision Date2023-06-22
Product CodeMUH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

QuickRayPRO is the device name listed in this FDA 510(k) record. The listed applicant is Denterprise International, Inc.. It received FDA 510(k) clearance on 2023-06-22 under 510(k) number K231202. 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 QuickRayPRO?

QuickRayPRO is a medical device that received FDA 510(k) clearance on 2023-06-22. The listed applicant is Denterprise International, Inc.. The 510(k) number is K231202.

When did QuickRayPRO receive FDA 510(k) clearance?

QuickRayPRO received FDA 510(k) clearance on 2023-06-22, under 510(k) number K231202.

Who is the listed applicant for QuickRayPRO?

The FDA 510(k) record lists Denterprise International, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for QuickRayPRO?

The FDA product code for QuickRayPRO is MUH.

Other records listing Denterprise International, Inc. 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.

K180561MobileX Portable X-ray System

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

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

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