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)

Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V2.4

K-Number: K173090 · 2018-01-11

ApplicantToshibamedical Systems Corporation
Decision Date2018-01-11
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V2.4 is a medical device manufactured by Toshibamedical Systems Corporation. It received FDA 510(k) clearance on 2018-01-11 under approval number K173090. 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 Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V2.4?

Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V2.4 is a medical device that received FDA 510(k) clearance on 2018-01-11. It is manufactured by Toshibamedical Systems Corporation. The 510(k) number is K173090.

When was Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V2.4 approved by the FDA?

Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V2.4 received FDA 510(k) clearance on 2018-01-11, under approval number K173090.

What company makes Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V2.4?

Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V2.4 is manufactured by Toshibamedical Systems Corporation.

What is the FDA product code for Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V2.4?

The FDA product code for Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V2.4 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

Other Devices by Toshibamedical Systems Corporation

K162183Vantage Galan 3T, MRT-3020, V4.0 K162155Xario 200 Diagnostic Ultrasound System V5.0 K162614Infinix, INFX-8000V, V6.35 K162187Xario 100 Diagnostic Ultrasound System, V5.0 K161843Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.0 K160632Vantage Titan 1.5T, MRT-1510, V3.6 Software

View all 27 devices →

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.

↑