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FDA 510(k)

GX-PAN PANORAMIC DENTAL X-RAY SYSTEM

K-Number: K952598 · 1995-06-29

ApplicantGendex Corp.
Decision Date1995-06-29
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

GX-PAN PANORAMIC DENTAL X-RAY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Gendex Corp.. It received FDA 510(k) clearance on 1995-06-29 under 510(k) number K952598. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GX-PAN PANORAMIC DENTAL X-RAY SYSTEM?

GX-PAN PANORAMIC DENTAL X-RAY SYSTEM is a medical device that received FDA 510(k) clearance on 1995-06-29. The listed applicant is Gendex Corp.. The 510(k) number is K952598.

When did GX-PAN PANORAMIC DENTAL X-RAY SYSTEM receive FDA 510(k) clearance?

GX-PAN PANORAMIC DENTAL X-RAY SYSTEM received FDA 510(k) clearance on 1995-06-29, under 510(k) number K952598.

Who is the listed applicant for GX-PAN PANORAMIC DENTAL X-RAY SYSTEM?

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-PAN PANORAMIC DENTAL X-RAY SYSTEM?

The FDA product code for GX-PAN PANORAMIC DENTAL X-RAY SYSTEM is GEX. This falls under the Gastroenterology category.

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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.

K945682PROCESSOR, RADIOGRAPHIC-FILM, AUTOMATIC, DENTALK935046GX-770 X-RAY CONTROL, MODEL 46-404600G4K925094VISUALIX RADIOGRAPHIC IMAGE DETECTING AND PROCESSK931001ORALIX DCK932675GXP DENTAL X-RAY PROCESSORK922165ATC725, ATC525, AND AP300

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Related Devices (Code: GEX)

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.

K254199PicoreMax (PicoreMax)BLUECORE COMPANY Co., Ltd.K252723Dynamis Pro FamilyFotona D.O.O.K241973SmartIPL_NI SystemLumenis Be, Ltd.K261047Dental Diode Laser Device (Laser-Pen)Guilin Kevin Peter Technology Co., Ltd.K261817Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.K261673LED Therapy Device (QLXY-01)Beijing Nubway S&T 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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