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)

ViewMate Multi Ultrasound System

K-Number: K222754 · 2022-11-09

ApplicantShenzhen Mindray Bio-Meidcal Electronics Co., Ltd.
Decision Date2022-11-09
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ViewMate Multi Ultrasound System is a medical device manufactured by Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.. It received FDA 510(k) clearance on 2022-11-09 under approval number K222754. 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 ViewMate Multi Ultrasound System?

ViewMate Multi Ultrasound System is a medical device that received FDA 510(k) clearance on 2022-11-09. It is manufactured by Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.. The 510(k) number is K222754.

When was ViewMate Multi Ultrasound System approved by the FDA?

ViewMate Multi Ultrasound System received FDA 510(k) clearance on 2022-11-09, under approval number K222754.

What company makes ViewMate Multi Ultrasound System?

ViewMate Multi Ultrasound System is manufactured by Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd..

What is the FDA product code for ViewMate Multi Ultrasound System?

The FDA product code for ViewMate Multi Ultrasound System is IYN.

Related Clinical Trials

NCT07191067 Pivotal Study on the NOVABLOC System for Patients Undergoing Primary Total Knee Arthroplasty RECRUITING 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 NCT07458243 A Prospective, Multicenter, Single Arm Registry of ENROUTE NPS in Conjunction With Carotid WALLSTENT in Chinese Population NOT_YET_RECRUITING NCT04981223 Predicting Location and Extent of Prostate Cancer Using Micro-Ultrasound Imaging COMPLETED NCT06735534 Repeat Ablation of Persistent Atrial Fibrillation, Including Mitral Isthmus Catheter Ablation, With the FARAPULSE Pulsed Field Ablation System RECRUITING

Related PubMed Literature

PMID: 29258356 Grave fraudulence in medical device research: a narrative review of the PIN seeding study for the Pinnacle hip system. Accountability in research (2018)

Other Devices by Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.

K173369DC-30/DC-32/DC-28/DC-26/DC-25 Diagnostic Ultrasound System K171233Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System K170712Accutorr 7/VS-900 Vital Signs Monitor K202785Resona R9,Resona R9 Exp,Resona R9 Pro,Resona R9S, Nuewa R9,Nuewa R9 Exp,Nuewa R9 Pro,Nuewa R9S,Resona 7,Resona 7CV,Resona 7EXP,Resona 7S, Resona 7OB,Resona 7PRO,Imagyn 7,Resona Y Diagnostic Ultrasound System K221267VS 8 Vital Signs Monitor, VS 8A Vital Signs Monitor, VS 9 Vital Signs Monitor

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.

↑