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FDA 510(k)

UC-5000 Mobile X-Ray

K-Number: K163063 · 2016-12-12

ApplicantSource-Ray, Inc.
Decision Date2016-12-12
Product CodeIZL
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

UC-5000 Mobile X-Ray is the device name listed in this FDA 510(k) record. The listed applicant is Source-Ray, Inc.. It received FDA 510(k) clearance on 2016-12-12 under 510(k) number K163063. 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 UC-5000 Mobile X-Ray?

UC-5000 Mobile X-Ray is a medical device that received FDA 510(k) clearance on 2016-12-12. The listed applicant is Source-Ray, Inc.. The 510(k) number is K163063.

When did UC-5000 Mobile X-Ray receive FDA 510(k) clearance?

UC-5000 Mobile X-Ray received FDA 510(k) clearance on 2016-12-12, under 510(k) number K163063.

Who is the listed applicant for UC-5000 Mobile X-Ray?

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

What is the FDA product code for UC-5000 Mobile X-Ray?

The FDA product code for UC-5000 Mobile X-Ray is IZL.

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.

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.K251710Mobile X-ray unit (!M1)Solutions For Tomorrow AB

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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