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FDA 510(k)

AIR TECHNIQUES HIGH FREQUENCY INTRA-ORAL X-RAY

K-Number: K111330 · 2011-05-27

ApplicantSkanray Technologies
Decision Date2011-05-27
Product CodeEHD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

AIR TECHNIQUES HIGH FREQUENCY INTRA-ORAL X-RAY is the device name listed in this FDA 510(k) record. The listed applicant is Skanray Technologies. It received FDA 510(k) clearance on 2011-05-27 under 510(k) number K111330. 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 AIR TECHNIQUES HIGH FREQUENCY INTRA-ORAL X-RAY?

AIR TECHNIQUES HIGH FREQUENCY INTRA-ORAL X-RAY is a medical device that received FDA 510(k) clearance on 2011-05-27. The listed applicant is Skanray Technologies. The 510(k) number is K111330.

When did AIR TECHNIQUES HIGH FREQUENCY INTRA-ORAL X-RAY receive FDA 510(k) clearance?

AIR TECHNIQUES HIGH FREQUENCY INTRA-ORAL X-RAY received FDA 510(k) clearance on 2011-05-27, under 510(k) number K111330.

Who is the listed applicant for AIR TECHNIQUES HIGH FREQUENCY INTRA-ORAL X-RAY?

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

What is the FDA product code for AIR TECHNIQUES HIGH FREQUENCY INTRA-ORAL X-RAY?

The FDA product code for AIR TECHNIQUES HIGH FREQUENCY INTRA-ORAL X-RAY is EHD.

Related Clinical Trials

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.

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Other records listing Skanray Technologies 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.

K103579INTRA SKAN DC

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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