• Skip to primary navigation
  • Skip to main content
  • Skip to footer

SAGES

Reimagining surgical care for a healthier world

  • Home
    • COVID-19 Annoucements
    • Search
    • SAGES Home
    • SAGES Foundation Home
  • About
    • Who is SAGES?
    • SAGES Mission Statement
    • Advocacy
    • Strategic Plan, 2020-2023
    • Committees
      • Request to Join a SAGES Committee
      • SAGES Board of Governors
      • Officers and Representatives of the Society
      • Committee Chairs and Co-Chairs
      • Full Committee Rosters
      • SAGES Past Presidents
    • Donate to the SAGES Foundation
    • Awards
      • George Berci Award
      • Pioneer in Surgical Endoscopy
      • Excellence In Clinical Care
      • International Ambassador
      • IRCAD Visiting Fellowship
      • Social Justice and Health Equity
      • Excellence in Community Surgery
      • Distinguished Service
      • Early Career Researcher
      • Researcher in Training
      • Jeff Ponsky Master Educator
      • Excellence in Medical Leadership
      • Barbara Berci Memorial Award
      • Brandeis Scholarship
      • Advocacy Summit
      • RAFT Annual Meeting Abstract Contest and Awards
  • Meetings
    • NBT Innovation Weekend
    • SAGES Annual Meeting
      • 2023 Scientific Session Call For Abstracts
      • 2023 Emerging Technology Call For Abstracts
    • CME Claim Form
    • Industry
      • Advertising Opportunities
      • Exhibit Opportunities
      • Sponsorship Opportunities
    • Future Meetings
    • Past Meetings
      • SAGES 2022
      • SAGES 2021
    • Related Meetings Calendar
  • Join SAGES!
    • Membership Benefits
    • Membership Applications
      • Active Membership
      • Affiliate Membership
      • Associate Active Membership
      • Candidate Membership
      • International Membership
      • Medical Student Membership
    • Member News
      • Member Spotlight
      • Give the Gift of SAGES Membership
  • Patients
    • Healthy Sooner – Patient Information for Minimally Invasive Surgery
    • Patient Information Brochures
    • Choosing Wisely – An Initiative of the ABIM Foundation
    • All in the Recovery: Colorectal Cancer Alliance
    • Find a SAGES Member
  • Publications
    • SAGES Stories Podcast
    • SAGES Clinical / Practice / Training Guidelines, Statements, and Standards of Practice
    • Patient Information Brochures
    • TAVAC – Technology and Value Assessments
    • Surgical Endoscopy and Other Journal Information
    • SAGES Manuals
    • SCOPE – The SAGES Newsletter
    • COVID-19 Annoucements
    • Troubleshooting Guides
  • Education
    • OpiVoid.org
    • SAGES.TV Video Library
    • Safe Cholecystectomy Program
      • Safe Cholecystectomy Didactic Modules
    • Masters Program
      • SAGES Facebook Program Collaboratives
      • Acute Care Surgery
      • Bariatric
      • Biliary
      • Colorectal
      • Flexible Endoscopy (upper or lower)
      • Foregut
      • Hernia
      • Robotics
    • Educational Opportunities
    • HPB/Solid Organ Program
    • Courses for Residents
      • Advanced Courses
      • Basic Courses
    • Video Based Assessments (VBA)
    • Robotics Fellows Course
    • MIS Fellows Course
    • Facebook Livestreams
    • Free Webinars For Residents
    • SMART Enhanced Recovery Program
    • SAGES OR SAFETY Video
    • SAGES at Cine-Med
      • SAGES Top 21 MIS Procedures
      • SAGES Pearls
      • SAGES Flexible Endoscopy 101
      • SAGES Tips & Tricks of the Top 21
  • Opportunities
    • NEW-Area of Concentrated Training Seal (ACT)-Advanced Flexible Endoscopy-Coming Soon!
    • SAGES Fellowship Certification for Advanced GI MIS and Comprehensive Flexible Endoscopy
    • Multi-Society Foregut Fellowship Certification
    • SAGES Research Opportunities
    • Fundamentals of Laparoscopic Surgery
    • Fundamentals of Endoscopic Surgery
    • Fundamental Use of Surgical Energy
    • Job Board
    • SAGES Go Global: Global Affairs and Humanitarian Efforts
  • Search
    • Search All SAGES Content
    • Search SAGES Guidelines
    • Search the Video Library
    • Search the Image Library
    • Search the Abstracts Archive
  • Store
    • “Unofficial” Logo Products
  • Log In

SONON Ultrasound Imaging System, Model 300L

May 2, 2019 by Souheil Adra

Souheil Adra, MD

Healcerion Co., Ltd received FDA approval for SONON Ultrasound Imaging System, Model 300L on 10/12/2017.

The SONON 300L is a battery-operated, hand-held wireless ultrasound system. Clinical applications for this device include imaging for musculoskeletal, vascular, breast, thyroid, thoracic/pleural motion and fluid detection imaging.

This device wirelessly transmits ultrasound images to an off-the-shelf commercial device running an app utilizing iOS or Android operating systems. The app will allow the images to be displayed onto the screen of the device with a size ranging from 4-10 inches depending whether a mobile phone or a tablet is used.  The probe possesses a linear array and it emits 5MHz, 7.5MHz, and 10MHz pulsed-echo and Doppler ultrasound waves, as well as B mode and color scan

The device met non-clinical performance criteria for electrical safety, acoustic output levels, clinical measurement range, display performance, usability, failure mode and risk analysis, biocompatibility, and cybersecurity.  No clinical tests or animal studies were needed due to its similarity to predicate devices.

The FDA has determined this device to be substantially equivalent to predicate devices: SONON 300C and Clarius Ultrasound System.

Indications:

Intended for use by healthcare professionals in a hospital, clinic, and medical office settings.

Intended for diagnostic ultrasound echo imaging, measurement, and analysis of the human body for general clinical applications including musculoskeletal (MSK), vascular, small parts (breast, thyroid), and thoracic/pleural motion and fluid detection imaging.

Contraindications:

None listedSONON 300L

 

1,550

Share this:

  • Twitter
  • Facebook
  • LinkedIn
  • Pinterest
  • WhatsApp
  • Reddit

Related

Contact SAGES

Society of American Gastrointestinal and Endoscopic Surgeons
11300 W. Olympic Blvd Suite 600
Los Angeles, CA 90064 USA
webmaster@sages.org
Tel: (310) 437-0544

Find Us Around the Web!

  • Facebook
  • Twitter
  • YouTube

Important Links

SAGES 2023 Meeting Information

Healthy Sooner: Patient Information

SAGES Guidelines, Statements, & Standards of Practice

SAGES Manuals

 

  • taTME Study Info
  • Foundation
  • SAGES.TV
  • MyCME
  • Educational Activities

Copyright © 2023 Society of American Gastrointestinal and Endoscopic Surgeons