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FDA 510(k)

ELITY 70 X-RAY

K-Number: K043136 · 2005-01-06

ApplicantDental X-Ray E.U.
Decision Date2005-01-06
Product CodeEHD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ELITY 70 X-RAY is the device name listed in this FDA 510(k) record. The listed applicant is Dental X-Ray E.U.. It received FDA 510(k) clearance on 2005-01-06 under 510(k) number K043136. 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 ELITY 70 X-RAY?

ELITY 70 X-RAY is a medical device that received FDA 510(k) clearance on 2005-01-06. The listed applicant is Dental X-Ray E.U.. The 510(k) number is K043136.

When did ELITY 70 X-RAY receive FDA 510(k) clearance?

ELITY 70 X-RAY received FDA 510(k) clearance on 2005-01-06, under 510(k) number K043136.

Who is the listed applicant for ELITY 70 X-RAY?

The FDA 510(k) record lists Dental X-Ray E.U. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ELITY 70 X-RAY?

The FDA product code for ELITY 70 X-RAY 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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