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FDA 510(k)

X-RAY, TOMOGRAPHY, COMPUTED, DENTAL

K-Number: K083917 · 2009-06-02

ApplicantSuni Medical Imaging, Inc.
Decision Date2009-06-02
Product CodeOAS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

X-RAY, TOMOGRAPHY, COMPUTED, DENTAL is the device name listed in this FDA 510(k) record. The listed applicant is Suni Medical Imaging, Inc.. It received FDA 510(k) clearance on 2009-06-02 under 510(k) number K083917. 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 X-RAY, TOMOGRAPHY, COMPUTED, DENTAL?

X-RAY, TOMOGRAPHY, COMPUTED, DENTAL is a medical device that received FDA 510(k) clearance on 2009-06-02. The listed applicant is Suni Medical Imaging, Inc.. The 510(k) number is K083917.

When did X-RAY, TOMOGRAPHY, COMPUTED, DENTAL receive FDA 510(k) clearance?

X-RAY, TOMOGRAPHY, COMPUTED, DENTAL received FDA 510(k) clearance on 2009-06-02, under 510(k) number K083917.

Who is the listed applicant for X-RAY, TOMOGRAPHY, COMPUTED, DENTAL?

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

What is the FDA product code for X-RAY, TOMOGRAPHY, COMPUTED, DENTAL?

The FDA product code for X-RAY, TOMOGRAPHY, COMPUTED, DENTAL is OAS.

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Other records listing Suni Medical Imaging, 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.

K162585SuniIQ Digital Radiography SystemK070219SUNIRAY II DIGITAL RADIOGRAPHY SYSTEMK060149SUNIPAN IMAGING SYSTEM & ACCESSORIES

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

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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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