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FDA 510(k)

GX-770 X-RAY CONTROL, MODEL 46-404600G4

K-Number: K935046 · 1994-02-18

ApplicantGendex Corp.
Decision Date1994-02-18
Product CodeEHD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

GX-770 X-RAY CONTROL, MODEL 46-404600G4 is the device name listed in this FDA 510(k) record. The listed applicant is Gendex Corp.. It received FDA 510(k) clearance on 1994-02-18 under 510(k) number K935046. 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 GX-770 X-RAY CONTROL, MODEL 46-404600G4?

GX-770 X-RAY CONTROL, MODEL 46-404600G4 is a medical device that received FDA 510(k) clearance on 1994-02-18. The listed applicant is Gendex Corp.. The 510(k) number is K935046.

When did GX-770 X-RAY CONTROL, MODEL 46-404600G4 receive FDA 510(k) clearance?

GX-770 X-RAY CONTROL, MODEL 46-404600G4 received FDA 510(k) clearance on 1994-02-18, under 510(k) number K935046.

Who is the listed applicant for GX-770 X-RAY CONTROL, MODEL 46-404600G4?

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

What is the FDA product code for GX-770 X-RAY CONTROL, MODEL 46-404600G4?

The FDA product code for GX-770 X-RAY CONTROL, MODEL 46-404600G4 is EHD.

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Other records listing Gendex Corp. 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.

K952598GX-PAN PANORAMIC DENTAL X-RAY SYSTEMK945682PROCESSOR, RADIOGRAPHIC-FILM, AUTOMATIC, DENTALK925094VISUALIX RADIOGRAPHIC IMAGE DETECTING AND PROCESSK931001ORALIX DCK932675GXP DENTAL X-RAY PROCESSORK922165ATC725, ATC525, AND AP300

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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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