Labat series Diagnostic Ultrasound System
K-Number: K210154 · 2021-07-30
Decision Date2021-07-30
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Labat series Diagnostic Ultrasound System is a medical device manufactured by Shenzhen Wisonic Medical Technology Co. , Ltd.. It received FDA 510(k) clearance on 2021-07-30 under approval number K210154. 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 Labat series Diagnostic Ultrasound System?
Labat series Diagnostic Ultrasound System is a medical device that received FDA 510(k) clearance on 2021-07-30. It is manufactured by Shenzhen Wisonic Medical Technology Co. , Ltd.. The 510(k) number is K210154.
When was Labat series Diagnostic Ultrasound System approved by the FDA?
Labat series Diagnostic Ultrasound System received FDA 510(k) clearance on 2021-07-30, under approval number K210154.
What company makes Labat series Diagnostic Ultrasound System?
Labat series Diagnostic Ultrasound System is manufactured by Shenzhen Wisonic Medical Technology Co. , Ltd..
What is the FDA product code for Labat series Diagnostic Ultrasound System?
The FDA product code for Labat series Diagnostic Ultrasound System is IYN.
Related Clinical Trials
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
NCT04981223
Predicting Location and Extent of Prostate Cancer Using Micro-Ultrasound Imaging
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: 41251011
Effectivity of the Dehydrated Human Amnion/Chorion Membrane Allograft for Diabetic Foot Ulcers in Japan: A Case Series.
International wound journal (2025)
PMID: 39943397
Clinical Validation of a Video-Otoscopy-Based Medical Device for the Remote Diagnosis of Ear Complaints.
Sensors (Basel, Switzerland) (2025)
Other Devices by Shenzhen Wisonic Medical Technology Co. , Ltd.
K182715Piloter Exp/Piloter/Piloter P Diagnostic Ultrasound System
K180461Navi e/Navi s/Navi X Diagnostic Ultrasound System
K163712Clover 50/Clover60/Clover70 Diagnostic Ultrasound System
K191347Paragon XHD Diagnostic Ultrasound System
K211886Clivia series Diagnostic Ultrasound System
K230066Carnation series Diagnostic Ultrasound 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.