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FDA 510(k)

SR-8100 Portable X-ray Unit

K-Number: K200637 · 2020-07-09

ApplicantShantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)
Decision Date2020-07-09
Product CodeIZL
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SR-8100 Portable X-ray Unit is a medical device manufactured by Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui). It received FDA 510(k) clearance on 2020-07-09 under approval number K200637. 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-8100 Portable X-ray Unit?

SR-8100 Portable X-ray Unit is a medical device that received FDA 510(k) clearance on 2020-07-09. It is manufactured by Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui). The 510(k) number is K200637.

When was SR-8100 Portable X-ray Unit approved by the FDA?

SR-8100 Portable X-ray Unit received FDA 510(k) clearance on 2020-07-09, under approval number K200637.

What company makes SR-8100 Portable X-ray Unit?

SR-8100 Portable X-ray Unit is manufactured by Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui).

What is the FDA product code for SR-8100 Portable X-ray Unit?

The FDA product code for SR-8100 Portable X-ray Unit is IZL.

Other Devices by Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)

K160853Apogee 5500/Apogee 5300/ Apogee 5800 Digital Color Doppler Ultrasound Imaging System K173000Apogee 2100 Digital Color Doppler Ultrasound Imaging System Apogee 2300 Digital Color Doppler Ultrasound Imaging System K202353SR-2300 Portable DR Imaging System, SR-2300S Portable DR Imaging System K200976SR-8230, SR-8230S Portable X-ray Unit K210317Apogee 1000/ Apogee 1000Neo/ Apogee 1000Lite/ Apogee 1000Exp/ Apogee 1000B/W / Apogee 1U/ Apogee 1T/ Apogee 1G Digital Color Doppler Ultrasound Imaging System K210318Apogee 6500,Apogee 6300,Apogee 6200 Digital Color Doppler Ultrasound Imaging System

View all 8 devices →

Related Devices (Code: IZL)

K163063UC-5000 Mobile X-RaySource-Ray, Inc. K162990Optima XR240amxGe Medical Systems, LLC K162278Digital Diagnostic Mobile X-ray SystemSamsung Electronics Co., Ltd. K162687Paragon 2Meridian Medical Systems, LLC K161345RadPRO® Mobile 40kW; RadPRO® Mobile 40kW FLEXPLUS, Model SM-40HF-B-D-VIRSedecal., Sa. K153059HF1202H PowerPlus Portable X-ray EquipmentMinxray, Inc.

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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