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FDA 510(k)

510 BEDSIDE X-RAY SYSTEM

K-Number: K780947 · 1978-06-22

ApplicantUnion Carbide Corp.
Decision Date1978-06-22
Product CodeIZL
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

510 BEDSIDE X-RAY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Union Carbide Corp.. It received FDA 510(k) clearance on 1978-06-22 under 510(k) number K780947. 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 510 BEDSIDE X-RAY SYSTEM?

510 BEDSIDE X-RAY SYSTEM is a medical device that received FDA 510(k) clearance on 1978-06-22. The listed applicant is Union Carbide Corp.. The 510(k) number is K780947.

When did 510 BEDSIDE X-RAY SYSTEM receive FDA 510(k) clearance?

510 BEDSIDE X-RAY SYSTEM received FDA 510(k) clearance on 1978-06-22, under 510(k) number K780947.

Who is the listed applicant for 510 BEDSIDE X-RAY SYSTEM?

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

What is the FDA product code for 510 BEDSIDE X-RAY SYSTEM?

The FDA product code for 510 BEDSIDE X-RAY SYSTEM is IZL.

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Other records listing Union Carbide Corp. as applicant

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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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