V8 Diagnostic Ultrasound System
K-Number: K211945 · 2021-09-08
ApplicantSamsung Medison Co., Ltd.
Decision Date2021-09-08
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
V8 Diagnostic Ultrasound System is a medical device manufactured by Samsung Medison Co., Ltd.. It received FDA 510(k) clearance on 2021-09-08 under approval number K211945. 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 V8 Diagnostic Ultrasound System?
V8 Diagnostic Ultrasound System is a medical device that received FDA 510(k) clearance on 2021-09-08. It is manufactured by Samsung Medison Co., Ltd.. The 510(k) number is K211945.
When was V8 Diagnostic Ultrasound System approved by the FDA?
V8 Diagnostic Ultrasound System received FDA 510(k) clearance on 2021-09-08, under approval number K211945.
What company makes V8 Diagnostic Ultrasound System?
V8 Diagnostic Ultrasound System is manufactured by Samsung Medison Co., Ltd..
What is the FDA product code for V8 Diagnostic Ultrasound System?
The FDA product code for V8 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
NCT05857852
Low-Intensity Focused Ultrasound for Cocaine Use Disorder
COMPLETED
NCT04981223
Predicting Location and Extent of Prostate Cancer Using Micro-Ultrasound Imaging
COMPLETED
NCT07608614
Sleep and Performance
RECRUITING
Related PubMed Literature
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: 39943397
Clinical Validation of a Video-Otoscopy-Based Medical Device for the Remote Diagnosis of Ear Complaints.
Sensors (Basel, Switzerland) (2025)
PMID: 39892748
Long-term Safety and Performance of a Suprachoroidal Pressure Sensor System: Results of the EYEMATE-SC Trial Follow-up Study.
Ophthalmology (2025)
Other Devices by Samsung Medison Co., Ltd.
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.