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FDA 510(k)

EdgeLife Handheld Wireless Ultrasound System (E8200); EdgeLife Handheld Wireless Ultrasound System (E8220)

K-Number: K234153 · 2024-09-18

ApplicantEdgelife Technologies, LLC
Decision Date2024-09-18
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

EdgeLife Handheld Wireless Ultrasound System (E8200); EdgeLife Handheld Wireless Ultrasound System (E8220) is a medical device manufactured by Edgelife Technologies, LLC. It received FDA 510(k) clearance on 2024-09-18 under approval number K234153. 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 EdgeLife Handheld Wireless Ultrasound System (E8200); EdgeLife Handheld Wireless Ultrasound System (E8220)?

EdgeLife Handheld Wireless Ultrasound System (E8200); EdgeLife Handheld Wireless Ultrasound System (E8220) is a medical device that received FDA 510(k) clearance on 2024-09-18. It is manufactured by Edgelife Technologies, LLC. The 510(k) number is K234153.

When was EdgeLife Handheld Wireless Ultrasound System (E8200); EdgeLife Handheld Wireless Ultrasound System (E8220) approved by the FDA?

EdgeLife Handheld Wireless Ultrasound System (E8200); EdgeLife Handheld Wireless Ultrasound System (E8220) received FDA 510(k) clearance on 2024-09-18, under approval number K234153.

What company makes EdgeLife Handheld Wireless Ultrasound System (E8200); EdgeLife Handheld Wireless Ultrasound System (E8220)?

EdgeLife Handheld Wireless Ultrasound System (E8200); EdgeLife Handheld Wireless Ultrasound System (E8220) is manufactured by Edgelife Technologies, LLC.

What is the FDA product code for EdgeLife Handheld Wireless Ultrasound System (E8200); EdgeLife Handheld Wireless Ultrasound System (E8220)?

The FDA product code for EdgeLife Handheld Wireless Ultrasound System (E8200); EdgeLife Handheld Wireless Ultrasound System (E8220) is IYN.

Related Clinical Trials

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 NCT04981223 Predicting Location and Extent of Prostate Cancer Using Micro-Ultrasound Imaging COMPLETED NCT07608614 Sleep and Performance RECRUITING NCT06559891 THRIVE- THerapeutic IntravasculaR Ultrasound (TIVUS™) REnal Denervation System Versus Sham for the Adjunctive Treatment of Hypertension RECRUITING NCT07095660 RECANA OUS - Recana Thrombectomy Catheter System for Venous Obstruction and Occlusion Study (RECANA-OUS-IRL) RECRUITING

Related PubMed Literature

PMID: 41160299 Toward safe clinical deployment of remote robotic surgery in Japan: five-year validation of the hinotori™ system using 5G wireless communication. International journal of clinical oncology (2025)

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.

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