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FDA 510(k)

X-RAY UNITS, GX-101, UCIS-510 AND GX-111

K-Number: K790451 · 1979-03-28

ApplicantGeneral X-Ray, Inc.
Decision Date1979-03-28
Product CodeIZL
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

X-RAY UNITS, GX-101, UCIS-510 AND GX-111 is the device name listed in this FDA 510(k) record. The listed applicant is General X-Ray, Inc.. It received FDA 510(k) clearance on 1979-03-28 under 510(k) number K790451. 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 X-RAY UNITS, GX-101, UCIS-510 AND GX-111?

X-RAY UNITS, GX-101, UCIS-510 AND GX-111 is a medical device that received FDA 510(k) clearance on 1979-03-28. The listed applicant is General X-Ray, Inc.. The 510(k) number is K790451.

When did X-RAY UNITS, GX-101, UCIS-510 AND GX-111 receive FDA 510(k) clearance?

X-RAY UNITS, GX-101, UCIS-510 AND GX-111 received FDA 510(k) clearance on 1979-03-28, under 510(k) number K790451.

Who is the listed applicant for X-RAY UNITS, GX-101, UCIS-510 AND GX-111?

The FDA 510(k) record lists General X-Ray, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for X-RAY UNITS, GX-101, UCIS-510 AND GX-111?

The FDA product code for X-RAY UNITS, GX-101, UCIS-510 AND GX-111 is IZL.

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Other records listing General X-Ray, Inc. 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.

K800998ATLAS-S X-RAY SYSTEM W/KETROMAT GEN.K790512PORTABLE X-RAY UNITK790393PORTABLE X-RAY UNIT, MATRIX S GX-101K790511MOBILE X-RAY UNITK790443PORTABLE X-RAY UNITK790392510 CARBINETTE X-RAY UNIT

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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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