FDA 510(k)

CBit Series Digital Color Doppler Ultrasound System

K-Number: K180974 · 2018-08-17

ApplicantCHISON Medical Technologies Co., Ltd.

Decision Date2018-08-17

Product CodeIYN

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

CBit Series Digital Color Doppler Ultrasound System is a medical device manufactured by CHISON Medical Technologies Co., Ltd.. It received FDA 510(k) clearance on 2018-08-17 under approval number K180974. 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 CBit Series Digital Color Doppler Ultrasound System?

CBit Series Digital Color Doppler Ultrasound System is a medical device that received FDA 510(k) clearance on 2018-08-17. It is manufactured by CHISON Medical Technologies Co., Ltd.. The 510(k) number is K180974.

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

CBit Series Digital Color Doppler Ultrasound System received FDA 510(k) clearance on 2018-08-17, under approval number K180974.

What company makes CBit Series Digital Color Doppler Ultrasound System?

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

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

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

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Other Devices by CHISON Medical Technologies Co., Ltd.

K200780XBit 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.