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FDA 510(k)

DENTAL EXTRAORAL SOURCE X-RAY SYSTEM (ESX)

K-Number: K092103 · 2009-10-09

ApplicantVATECH Co., Ltd.
Decision Date2009-10-09
Product CodeEHD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DENTAL EXTRAORAL SOURCE X-RAY SYSTEM (ESX) is the device name listed in this FDA 510(k) record. The listed applicant is VATECH Co., Ltd.. It received FDA 510(k) clearance on 2009-10-09 under 510(k) number K092103. The device is classified under product code EHD. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DENTAL EXTRAORAL SOURCE X-RAY SYSTEM (ESX)?

DENTAL EXTRAORAL SOURCE X-RAY SYSTEM (ESX) is a medical device that received FDA 510(k) clearance on 2009-10-09. The listed applicant is VATECH Co., Ltd.. The 510(k) number is K092103.

When did DENTAL EXTRAORAL SOURCE X-RAY SYSTEM (ESX) receive FDA 510(k) clearance?

DENTAL EXTRAORAL SOURCE X-RAY SYSTEM (ESX) received FDA 510(k) clearance on 2009-10-09, under 510(k) number K092103.

Who is the listed applicant for DENTAL EXTRAORAL SOURCE X-RAY SYSTEM (ESX)?

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

What is the FDA product code for DENTAL EXTRAORAL SOURCE X-RAY SYSTEM (ESX)?

The FDA product code for DENTAL EXTRAORAL SOURCE X-RAY SYSTEM (ESX) is EHD.

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Related Devices (Code: EHD)

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.

K260795Hand-held Dental X-ray System (HyperLight-M)Changzhou Sifary Medical Technology Co., Ltd.K260367Portable Dental X-ray System Model PDX novaPDX Co., Ltd.K253864NOMAD Pro 3Dental Imaging Technologies CorporationK252110Dental X-RAY Unit (AJX200)Guangzhou Ajax Medical Equipment Co., Ltd.K254018Portable Dental X-ray Device (GT-1)Guilin Refine Medical Instrument Co., Ltd.K252909Diagnostic X-Ray Equipment Model POCT22Ningbo Runyes Medical Instrument 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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