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FDA 510(k)

SONON Ultrasound Imaging System, Model: SONON 500L

K-Number: K212400 · 2022-04-22

ApplicantHealcerion Co., Ltd.
Decision Date2022-04-22
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SONON Ultrasound Imaging System, Model: SONON 500L is a medical device manufactured by Healcerion Co., Ltd.. It received FDA 510(k) clearance on 2022-04-22 under approval number K212400. 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 SONON Ultrasound Imaging System, Model: SONON 500L?

SONON Ultrasound Imaging System, Model: SONON 500L is a medical device that received FDA 510(k) clearance on 2022-04-22. It is manufactured by Healcerion Co., Ltd.. The 510(k) number is K212400.

When was SONON Ultrasound Imaging System, Model: SONON 500L approved by the FDA?

SONON Ultrasound Imaging System, Model: SONON 500L received FDA 510(k) clearance on 2022-04-22, under approval number K212400.

What company makes SONON Ultrasound Imaging System, Model: SONON 500L?

SONON Ultrasound Imaging System, Model: SONON 500L is manufactured by Healcerion Co., Ltd..

What is the FDA product code for SONON Ultrasound Imaging System, Model: SONON 500L?

The FDA product code for SONON Ultrasound Imaging System, Model: SONON 500L is IYN.

Related Clinical Trials

NCT01143454 Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System RECRUITING NCT06940752 VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms) Using Commercial Off-The-Shelf (COTS) Catheters ENROLLING_BY_INVITATION 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 NCT03331380 Technical Development of Cardiovascular Magnetic Resonance Imaging (CMR) Using a Low Specific Absorption Rate (SAR) Scanner System RECRUITING NCT07613476 Pregabalin Phonophoresis for Carpal Tunnel Syndrome Pain ACTIVE_NOT_RECRUITING

Related PubMed Literature

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: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025) PMID: 40346298 An attempt to evaluate the use of mixed reality in surgically treated pediatric oncology patients. NPJ digital medicine (2025)

Other Devices by Healcerion Co., Ltd.

K170085SONON Ultrasound Imaging System, Model: 300L K211665SONON Ultrasound Imaging System, Model: SONON300C

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.

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