P10 Series Digital Color Doppler Ultrasound System
K-Number: K173058 · 2017-12-01
ApplicantSonoscape Medical Corp.
Decision Date2017-12-01
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
P10 Series Digital Color Doppler Ultrasound System is a medical device manufactured by Sonoscape Medical Corp.. It received FDA 510(k) clearance on 2017-12-01 under approval number K173058. 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 P10 Series Digital Color Doppler Ultrasound System?
P10 Series Digital Color Doppler Ultrasound System is a medical device that received FDA 510(k) clearance on 2017-12-01. It is manufactured by Sonoscape Medical Corp.. The 510(k) number is K173058.
When was P10 Series Digital Color Doppler Ultrasound System approved by the FDA?
P10 Series Digital Color Doppler Ultrasound System received FDA 510(k) clearance on 2017-12-01, under approval number K173058.
What company makes P10 Series Digital Color Doppler Ultrasound System?
P10 Series Digital Color Doppler Ultrasound System is manufactured by Sonoscape Medical Corp..
What is the FDA product code for P10 Series Digital Color Doppler Ultrasound System?
The FDA product code for P10 Series Digital Color Doppler Ultrasound 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
NCT07614100
Cerebral Microembolization During Transcatheter Aortic Valve Implantation: Comparing Balloon-expandable and Self-expanding Valves
NOT_YET_RECRUITING
NCT07613476
Pregabalin Phonophoresis for Carpal Tunnel Syndrome Pain
ACTIVE_NOT_RECRUITING
NCT07613918
Brain Blood Flow and Cerebral Autoregulation Monitoring in Critically Ill Children
NOT_YET_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
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: 41734979
Strategies to Increase Patients' Adherence to Digital Therapeutics for Musculoskeletal Diseases: A Narrative Review.
Yonsei medical journal (2026)
PMID: 41491965
From stones to system: integrating kidney stones disease into the cardiovascular-kidney-metabolic continuum.
Current opinion in nephrology and hypertension (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)
Other Devices by Sonoscape Medical Corp.
K160283S45 Digital Color Doppler Ultrasound System
K160258X5 Digital Color Doppler Ultrasound System
K152854S50 Digital Color Doppler Ultrasound System
K172993P20 Series Digital Color Doppler Ultrasound System
K172082S60 Series Digital Color Doppler Ultrasound System
K170999P50 Series Digital Color Doppler 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.