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FDA 510(k)

INTRAORAL DENTAL X-RAY SYSTEM 70-X

K-Number: K851095 · 1985-09-03

ApplicantTrophy Radiologie
Decision Date1985-09-03
Product CodeEHD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

INTRAORAL DENTAL X-RAY SYSTEM 70-X is the device name listed in this FDA 510(k) record. The listed applicant is Trophy Radiologie. It received FDA 510(k) clearance on 1985-09-03 under 510(k) number K851095. 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 INTRAORAL DENTAL X-RAY SYSTEM 70-X?

INTRAORAL DENTAL X-RAY SYSTEM 70-X is a medical device that received FDA 510(k) clearance on 1985-09-03. The listed applicant is Trophy Radiologie. The 510(k) number is K851095.

When did INTRAORAL DENTAL X-RAY SYSTEM 70-X receive FDA 510(k) clearance?

INTRAORAL DENTAL X-RAY SYSTEM 70-X received FDA 510(k) clearance on 1985-09-03, under 510(k) number K851095.

Who is the listed applicant for INTRAORAL DENTAL X-RAY SYSTEM 70-X?

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

What is the FDA product code for INTRAORAL DENTAL X-RAY SYSTEM 70-X?

The FDA product code for INTRAORAL DENTAL X-RAY SYSTEM 70-X is EHD.

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Other records listing Trophy Radiologie as applicant

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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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