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FDA 510(k)

PreXion3D Explorer PRO

K-Number: K221525 · 2022-07-22

ApplicantPrexion Corporation
Decision Date2022-07-22
Product CodeOAS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PreXion3D Explorer PRO is the device name listed in this FDA 510(k) record. The listed applicant is Prexion Corporation. It received FDA 510(k) clearance on 2022-07-22 under 510(k) number K221525. The device is classified under product code OAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PreXion3D Explorer PRO?

PreXion3D Explorer PRO is a medical device that received FDA 510(k) clearance on 2022-07-22. The listed applicant is Prexion Corporation. The 510(k) number is K221525.

When did PreXion3D Explorer PRO receive FDA 510(k) clearance?

PreXion3D Explorer PRO received FDA 510(k) clearance on 2022-07-22, under 510(k) number K221525.

Who is the listed applicant for PreXion3D Explorer PRO?

The FDA 510(k) record lists Prexion Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PreXion3D Explorer PRO?

The FDA product code for PreXion3D Explorer PRO is OAS.

Other records listing Prexion Corporation 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.

K232166PreXion3D ExpeditionK222150PreXion3D ExpeditionK203784PreXion3D Explorer PROK193329PreXion3D Explorer EXK190320PreXion3D ExplorerK181983PreXion 3D Excelsior

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Related Devices (Code: OAS)

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.

K261748Dental Cone-beam Computed Tomography (mDX-15P Series)Hefei Meyer Optoelectronic Technology, Inc.K250839Dental X-ray SystemChangzhou Boen Zhongding Medical Technology Co., Ltd.K260662Dental Cone Beam Computed Tomography SystemYofo Medical Technology Co., Ltd.K253935medXion NEXUSmedXion Technologies, Inc.K260462RCT800Ray Co., Ltd.K260093Green X 12 VE (PHT-70CHS); Green X VE (PHT-70CHS)VATECH Co., Ltd.

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.

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