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FDA 510(k)

CareView 750Cw/750C X-ray Flat Panel Detectors

K-Number: K163019 · 2016-12-01

ApplicantCareray Digital Medical System Co., Ltd.
Decision Date2016-12-01
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CareView 750Cw/750C X-ray Flat Panel Detectors is a medical device manufactured by Careray Digital Medical System Co., Ltd.. It received FDA 510(k) clearance on 2016-12-01 under approval number K163019. The device is classified under product code MQB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CareView 750Cw/750C X-ray Flat Panel Detectors?

CareView 750Cw/750C X-ray Flat Panel Detectors is a medical device that received FDA 510(k) clearance on 2016-12-01. It is manufactured by Careray Digital Medical System Co., Ltd.. The 510(k) number is K163019.

When was CareView 750Cw/750C X-ray Flat Panel Detectors approved by the FDA?

CareView 750Cw/750C X-ray Flat Panel Detectors received FDA 510(k) clearance on 2016-12-01, under approval number K163019.

What company makes CareView 750Cw/750C X-ray Flat Panel Detectors?

CareView 750Cw/750C X-ray Flat Panel Detectors is manufactured by Careray Digital Medical System Co., Ltd..

What is the FDA product code for CareView 750Cw/750C X-ray Flat Panel Detectors?

The FDA product code for CareView 750Cw/750C X-ray Flat Panel Detectors is MQB.

Other Devices by Careray Digital Medical System Co., Ltd.

K162178CareView 1500P X-ray Flat Panel Detectors K172581CareView 1800Cw X-ray Flat Panel Detectors K193173CareView 1800Le K201932X-ray Flat Panel Detectors (CareView 1800Cwe /CareView 1500Cwe) K202995X-ray Flat Panel Detectors/CareView 3600RF

Related Devices (Code: MQB)

K162555EVS 4343, EVS 4343GDRTECH Corporation K162344INNOLUX RICInnolux Corporation K161730Wireless Digital Flat Panel DetectorIray Technology (Shanghai) , Ltd. K162552EVS 3643, EVS 3643GDRTECH Corporation K160143ClearVision ExamVue Flat Panel DetectorJpi Healthcare, Inc. K162487BSD3543 Digital Flat Panel X-ray DetectorBontech, Inc.

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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