FDA 510(k)

SR-1000 Portable DR Imaging System, SR-1000S Portable DR Imaging System

K-Number: K202350 · 2021-01-06

ApplicantShantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)

Decision Date2021-01-06

Product CodeIZL

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

SR-1000 Portable DR Imaging System, SR-1000S Portable DR Imaging System is a medical device manufactured by Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui). It received FDA 510(k) clearance on 2021-01-06 under approval number K202350. 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-1000 Portable DR Imaging System, SR-1000S Portable DR Imaging System?

SR-1000 Portable DR Imaging System, SR-1000S Portable DR Imaging System is a medical device that received FDA 510(k) clearance on 2021-01-06. It is manufactured by Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui). The 510(k) number is K202350.

When was SR-1000 Portable DR Imaging System, SR-1000S Portable DR Imaging System approved by the FDA?

SR-1000 Portable DR Imaging System, SR-1000S Portable DR Imaging System received FDA 510(k) clearance on 2021-01-06, under approval number K202350.

What company makes SR-1000 Portable DR Imaging System, SR-1000S Portable DR Imaging System?

SR-1000 Portable DR Imaging System, SR-1000S Portable DR Imaging System is manufactured by Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui).

What is the FDA product code for SR-1000 Portable DR Imaging System, SR-1000S Portable DR Imaging System?

The FDA product code for SR-1000 Portable DR Imaging System, SR-1000S Portable DR Imaging System is IZL.

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Related PubMed Literature

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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 K200637SR-8100 Portable X-ray Unit 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

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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.