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FDA 510(k)

SR-2300 Portable DR Imaging System, SR-2300S Portable DR Imaging System

K-Number: K202353 · 2020-12-23

ApplicantShantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)
Decision Date2020-12-23
Product CodeIZL
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SR-2300 Portable DR Imaging System, SR-2300S Portable DR Imaging System 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 2020-12-23 under 510(k) number K202353. 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-2300 Portable DR Imaging System, SR-2300S Portable DR Imaging System?

SR-2300 Portable DR Imaging System, SR-2300S Portable DR Imaging System is a medical device that received FDA 510(k) clearance on 2020-12-23. The listed applicant is Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui). The 510(k) number is K202353.

When did SR-2300 Portable DR Imaging System, SR-2300S Portable DR Imaging System receive FDA 510(k) clearance?

SR-2300 Portable DR Imaging System, SR-2300S Portable DR Imaging System received FDA 510(k) clearance on 2020-12-23, under 510(k) number K202353.

Who is the listed applicant for SR-2300 Portable DR Imaging System, SR-2300S Portable DR Imaging System?

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-2300 Portable DR Imaging System, SR-2300S Portable DR Imaging System?

The FDA product code for SR-2300 Portable DR Imaging System, SR-2300S Portable DR Imaging System is IZL.

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

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.

K210317Apogee 1000/ Apogee 1000Neo/ Apogee 1000Lite/ Apogee 1000Exp/ Apogee 1000B/W / Apogee 1U/ Apogee 1T/ Apogee 1G Digital Color Doppler Ultrasound Imaging SystemK210318Apogee 6500,Apogee 6300,Apogee 6200 Digital Color Doppler Ultrasound Imaging SystemK202350SR-1000 Portable DR Imaging System, SR-1000S Portable DR Imaging SystemK200637SR-8100 Portable X-ray UnitK200976SR-8230, SR-8230S Portable X-ray UnitK173000Apogee 2100 Digital Color Doppler Ultrasound Imaging System Apogee 2300 Digital Color Doppler Ultrasound Imaging System

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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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