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FDA 510(k)

GX-MOBILE X-RAY UNIT

K-Number: K873982 · 1987-10-30

ApplicantGendex Corp.
Decision Date1987-10-30
Product CodeIZL
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

GX-MOBILE X-RAY UNIT is the device name listed in this FDA 510(k) record. The listed applicant is Gendex Corp.. It received FDA 510(k) clearance on 1987-10-30 under 510(k) number K873982. The device is classified under product code IZL. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GX-MOBILE X-RAY UNIT?

GX-MOBILE X-RAY UNIT is a medical device that received FDA 510(k) clearance on 1987-10-30. The listed applicant is Gendex Corp.. The 510(k) number is K873982.

When did GX-MOBILE X-RAY UNIT receive FDA 510(k) clearance?

GX-MOBILE X-RAY UNIT received FDA 510(k) clearance on 1987-10-30, under 510(k) number K873982.

Who is the listed applicant for GX-MOBILE X-RAY UNIT?

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-MOBILE X-RAY UNIT?

The FDA product code for GX-MOBILE X-RAY UNIT is IZL.

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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, DENTALK935046GX-770 X-RAY CONTROL, MODEL 46-404600G4K925094VISUALIX RADIOGRAPHIC IMAGE DETECTING AND PROCESSK931001ORALIX DCK932675GXP DENTAL X-RAY PROCESSOR

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Related Devices (Code: IZL)

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.

K260236XLITEGEMSS HEALTHCARE CO., LTD.K253058Portable DR Imaging SystemShantou Institute of Ultrasonic Instruments Co., Ltd.K260085RAYMO Mobile X-ray System (Model: RAYMO)DRGEM CorporationK253185Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray SystemCarestream HealthK253244AirRay-mini 80A, AirRay-mini 90A, AirRay-mini 80F, AirRay-mini 90F (AirRay-mini)Poskom Co., Ltd.K250976Airbile-100Poskom 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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