FDA 510(k)

Apogee 2100 Digital Color Doppler Ultrasound Imaging System Apogee 2300 Digital Color Doppler Ultrasound Imaging System

K-Number: K173000 · 2017-12-07

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

Decision Date2017-12-07

Product CodeIYN

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Apogee 2100 Digital Color Doppler Ultrasound Imaging System Apogee 2300 Digital Color Doppler Ultrasound 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 2017-12-07 under 510(k) number K173000. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Apogee 2100 Digital Color Doppler Ultrasound Imaging System Apogee 2300 Digital Color Doppler Ultrasound Imaging System?

Apogee 2100 Digital Color Doppler Ultrasound Imaging System Apogee 2300 Digital Color Doppler Ultrasound Imaging System is a medical device that received FDA 510(k) clearance on 2017-12-07. The listed applicant is Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui). The 510(k) number is K173000.

When did Apogee 2100 Digital Color Doppler Ultrasound Imaging System Apogee 2300 Digital Color Doppler Ultrasound Imaging System receive FDA 510(k) clearance?

Apogee 2100 Digital Color Doppler Ultrasound Imaging System Apogee 2300 Digital Color Doppler Ultrasound Imaging System received FDA 510(k) clearance on 2017-12-07, under 510(k) number K173000.

Who is the listed applicant for Apogee 2100 Digital Color Doppler Ultrasound Imaging System Apogee 2300 Digital Color Doppler Ultrasound 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 Apogee 2100 Digital Color Doppler Ultrasound Imaging System Apogee 2300 Digital Color Doppler Ultrasound Imaging System?

The FDA product code for Apogee 2100 Digital Color Doppler Ultrasound Imaging System Apogee 2300 Digital Color Doppler Ultrasound Imaging System is IYN.

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

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 K202350SR-1000 Portable DR Imaging System, SR-1000S Portable DR 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

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Related Devices (Code: IYN)

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.