FDA 510(k)

XBit Series Digital Color Doppler Ultrasound System

K-Number: K200780 · 2020-08-05

ApplicantCHISON Medical Technologies Co., Ltd.

Decision Date2020-08-05

Product CodeIYN

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

XBit Series Digital Color Doppler Ultrasound System is a medical device manufactured by CHISON Medical Technologies Co., Ltd.. It received FDA 510(k) clearance on 2020-08-05 under approval number K200780. 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 XBit Series Digital Color Doppler Ultrasound System?

XBit Series Digital Color Doppler Ultrasound System is a medical device that received FDA 510(k) clearance on 2020-08-05. It is manufactured by CHISON Medical Technologies Co., Ltd.. The 510(k) number is K200780.

When was XBit Series Digital Color Doppler Ultrasound System approved by the FDA?

XBit Series Digital Color Doppler Ultrasound System received FDA 510(k) clearance on 2020-08-05, under approval number K200780.

What company makes XBit Series Digital Color Doppler Ultrasound System?

XBit Series Digital Color Doppler Ultrasound System is manufactured by CHISON Medical Technologies Co., Ltd..

What is the FDA product code for XBit Series Digital Color Doppler Ultrasound System?

The FDA product code for XBit Series Digital Color Doppler Ultrasound System is IYN.

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Other Devices by CHISON Medical Technologies Co., Ltd.

K180974CBit Series Digital Color Doppler Ultrasound System K202457M1 Surgical Face Mask K201965SonoEye P1/ SonoEye P1-G/ SonoEye V1/ SonoEye V1-G/ SonoEye G1/ SonoEye G1-G Digital Color Doppler Palm Ultrasound System K201968SonoEye P3/ SonoEye V3/ Sono Eye G3 Digital Color Doppler Palm Ultrasound System K201967SonoEye P2/ SonoEye V2/ SonoEye G2 Digital Color Doppler Palm Ultrasound System K201969SonoEye P6/ SonoEye V6/ SonoEye G6 Digital Color Doppler Palm Ultrasound System

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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.