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FDA 510(k)

ZS3 and z.one pro Ultrasound Systems

K-Number: K192410 · 2019-12-19

ApplicantShenzhen Mindray Bio-Medical Electronics Co., Ltd.
Decision Date2019-12-19
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ZS3 and z.one pro Ultrasound Systems is a medical device manufactured by Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. It received FDA 510(k) clearance on 2019-12-19 under approval number K192410. 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 ZS3 and z.one pro Ultrasound Systems?

ZS3 and z.one pro Ultrasound Systems is a medical device that received FDA 510(k) clearance on 2019-12-19. It is manufactured by Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. The 510(k) number is K192410.

When was ZS3 and z.one pro Ultrasound Systems approved by the FDA?

ZS3 and z.one pro Ultrasound Systems received FDA 510(k) clearance on 2019-12-19, under approval number K192410.

What company makes ZS3 and z.one pro Ultrasound Systems?

ZS3 and z.one pro Ultrasound Systems is manufactured by Shenzhen Mindray Bio-Medical Electronics Co., Ltd..

What is the FDA product code for ZS3 and z.one pro Ultrasound Systems?

The FDA product code for ZS3 and z.one pro Ultrasound Systems is IYN.

Related Clinical Trials

NCT07207356 Ultrasound Guided Transcutaneous Pulsed Radiofrequency for Cervical Radiculopathy RECRUITING NCT07508722 Transcranial Ultrasonic Neuromodulation of Primary Visual Cortex and Primary Auditory Cortex in Humans NOT_YET_RECRUITING

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

K162845DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound System K162267Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System K161525TE7 Diagnostic Ultrasound, TE5 Diagnostic Ultrasound System K160370BS-800M/ ABS800/BA-800M ISE KIT, BS-800M Chemistry Analyzer, BA-800M Chemistry Analyzer, ABS800 Chemistry Analyzer K160381TE7 Diagnostic Ultrasound System K153448Passport Series Patient Monitors (Including Passport 8, Passport 12)

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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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