Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

KOLO Evolution XHD Series Ultrasound Diagnostic System

K-Number: K221568 · 2022-09-12

ApplicantKolo Medical (Suzhou) Co., Ltd.
Decision Date2022-09-12
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

KOLO Evolution XHD Series Ultrasound Diagnostic System is a medical device manufactured by Kolo Medical (Suzhou) Co., Ltd.. It received FDA 510(k) clearance on 2022-09-12 under approval number K221568. 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 KOLO Evolution XHD Series Ultrasound Diagnostic System?

KOLO Evolution XHD Series Ultrasound Diagnostic System is a medical device that received FDA 510(k) clearance on 2022-09-12. It is manufactured by Kolo Medical (Suzhou) Co., Ltd.. The 510(k) number is K221568.

When was KOLO Evolution XHD Series Ultrasound Diagnostic System approved by the FDA?

KOLO Evolution XHD Series Ultrasound Diagnostic System received FDA 510(k) clearance on 2022-09-12, under approval number K221568.

What company makes KOLO Evolution XHD Series Ultrasound Diagnostic System?

KOLO Evolution XHD Series Ultrasound Diagnostic System is manufactured by Kolo Medical (Suzhou) Co., Ltd..

What is the FDA product code for KOLO Evolution XHD Series Ultrasound Diagnostic System?

The FDA product code for KOLO Evolution XHD Series Ultrasound Diagnostic System is IYN.

Related Clinical Trials

NCT01143558 Searching for Persistence of Infection in Lyme Disease COMPLETED NCT07040696 Accuracy of Venous Excess Ultrasound Score at Hospital Admission to Predict Acute Kidney Injury COMPLETED NCT01143454 Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System RECRUITING NCT07613476 Pregabalin Phonophoresis for Carpal Tunnel Syndrome Pain ACTIVE_NOT_RECRUITING NCT06642935 A Study to Explore Improved Features and a Simplified Treatment Approach for a Totally Implantable Cochlear Implant (TICI) Research System in Adults With Severe Hearing Loss ACTIVE_NOT_RECRUITING NCT05857852 Low-Intensity Focused Ultrasound for Cocaine Use Disorder COMPLETED

Related PubMed Literature

PMID: 42201559 Time-series and thematic analyses of clinical utilities and operational issues in early clinical studies of the da Vinci surgical system. Journal of robotic surgery (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: 41276747 Regulatory Challenges and Opportunities: A Review of U.S. Food and Drug Administration-Approved Artificial Intelligence and Machine Learning-Enabled Cardiovascular Devices. Therapeutic innovation & regulatory science (2026) PMID: 41251011 Effectivity of the Dehydrated Human Amnion/Chorion Membrane Allograft for Diabetic Foot Ulcers in Japan: A Case Series. International wound journal (2025)

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.

↑