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FDA 510(k)

SR-8230, SR-8230S Portable X-ray Unit

K-Number: K200976 · 2020-06-10

ApplicantShantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)
Decision Date2020-06-10
Product CodeIZL
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SR-8230, SR-8230S Portable X-ray Unit is the device name listed in this FDA 510(k) record. The listed applicant is Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui). It received FDA 510(k) clearance on 2020-06-10 under 510(k) number K200976. 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 SR-8230, SR-8230S Portable X-ray Unit?

SR-8230, SR-8230S Portable X-ray Unit is a medical device that received FDA 510(k) clearance on 2020-06-10. The listed applicant is Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui). The 510(k) number is K200976.

When did SR-8230, SR-8230S Portable X-ray Unit receive FDA 510(k) clearance?

SR-8230, SR-8230S Portable X-ray Unit received FDA 510(k) clearance on 2020-06-10, under 510(k) number K200976.

Who is the listed applicant for SR-8230, SR-8230S Portable X-ray Unit?

The FDA 510(k) record lists Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SR-8230, SR-8230S Portable X-ray Unit?

The FDA product code for SR-8230, SR-8230S Portable X-ray Unit is IZL.

Other records listing Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui) 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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