Apogee 6500,Apogee 6300,Apogee 6200 Digital Color Doppler Ultrasound Imaging System
K-Number: K210318 · 2021-08-18
Decision Date2021-08-18
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Apogee 6500,Apogee 6300,Apogee 6200 Digital Color Doppler Ultrasound Imaging System is a medical device manufactured by Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui). It received FDA 510(k) clearance on 2021-08-18 under approval number K210318. 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 6500,Apogee 6300,Apogee 6200 Digital Color Doppler Ultrasound Imaging System?
Apogee 6500,Apogee 6300,Apogee 6200 Digital Color Doppler Ultrasound Imaging System is a medical device that received FDA 510(k) clearance on 2021-08-18. It is manufactured by Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui). The 510(k) number is K210318.
When was Apogee 6500,Apogee 6300,Apogee 6200 Digital Color Doppler Ultrasound Imaging System approved by the FDA?
Apogee 6500,Apogee 6300,Apogee 6200 Digital Color Doppler Ultrasound Imaging System received FDA 510(k) clearance on 2021-08-18, under approval number K210318.
What company makes Apogee 6500,Apogee 6300,Apogee 6200 Digital Color Doppler Ultrasound Imaging System?
Apogee 6500,Apogee 6300,Apogee 6200 Digital Color Doppler Ultrasound Imaging System is manufactured by Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui).
What is the FDA product code for Apogee 6500,Apogee 6300,Apogee 6200 Digital Color Doppler Ultrasound Imaging System?
The FDA product code for Apogee 6500,Apogee 6300,Apogee 6200 Digital Color Doppler Ultrasound Imaging System is IYN.
Related Clinical Trials
NCT01143454
Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System
RECRUITING
NCT07301385
Evaluation of Head-Mounted Spatial Computing and Three-Dimensional (3D) Visualization in Ocular Microsurgery: A Safety and Workflow Study
ACTIVE_NOT_RECRUITING
NCT06940752
VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms) Using Commercial Off-The-Shelf (COTS) Catheters
ENROLLING_BY_INVITATION
NCT07614100
Cerebral Microembolization During Transcatheter Aortic Valve Implantation: Comparing Balloon-expandable and Self-expanding Valves
NOT_YET_RECRUITING
NCT07099092
Causal Mechanisms of Odor-Guided Behavior in Humans
NOT_YET_RECRUITING
NCT07615972
Efficacy of a Roller Device Facilitating Self-massage in the Treatment of Chronic Lateral Epicondylitis
NOT_YET_RECRUITING
Related PubMed Literature
PMID: 42204020
A Minimal UDI-DICOM Mapping Profile and Validation Artifact for Medical-Device Imaging Workflows.
Journal of imaging informatics in medicine (2026)
PMID: 41987469
[Progress and Prospects of Ultrasound Brain-Computer Interface Medical Devices Technology].
Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation (2026)
PMID: 41887630
Capacity building for ethical use of artificial intelligence in health: protocol for a scoping review of training initiatives and gaps in Africa.
BMJ open (2026)
PMID: 41883556
A clinician's quick‑start guide to implementing digital health innovations in the NHS - with lessons from a UK-deployed AI stroke imaging decision-support software.
Digital health (2026)
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
Related Devices (Code: IYN)
K162845DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.
K162902ARIETTA Prologue Diagnostic Ultrasound system and TransducersHitachi , Ltd.
K163138Clarius Ultrasound SystemClarius Mobile Health Corp.
K163077LOGIQ E9, LOGIQ E9 XDClear 2.0GE Medical Systems Ultrasound and Primary Care Diagnostics
K162583ALOKA LISENDO 880Hitachi , Ltd.
K163020Xperius Ultrasound SystemPhilips Health Care
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.