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FDA 510(k)

X-ray Flat Panel Detectors (CareView 1800Cwe /CareView 1500Cwe)

K-Number: K201932 · 2020-08-07

ApplicantCareray Digital Medical System Co., Ltd.
Decision Date2020-08-07
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

X-ray Flat Panel Detectors (CareView 1800Cwe /CareView 1500Cwe) is a medical device manufactured by Careray Digital Medical System Co., Ltd.. It received FDA 510(k) clearance on 2020-08-07 under approval number K201932. 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 X-ray Flat Panel Detectors (CareView 1800Cwe /CareView 1500Cwe)?

X-ray Flat Panel Detectors (CareView 1800Cwe /CareView 1500Cwe) is a medical device that received FDA 510(k) clearance on 2020-08-07. It is manufactured by Careray Digital Medical System Co., Ltd.. The 510(k) number is K201932.

When was X-ray Flat Panel Detectors (CareView 1800Cwe /CareView 1500Cwe) approved by the FDA?

X-ray Flat Panel Detectors (CareView 1800Cwe /CareView 1500Cwe) received FDA 510(k) clearance on 2020-08-07, under approval number K201932.

What company makes X-ray Flat Panel Detectors (CareView 1800Cwe /CareView 1500Cwe)?

X-ray Flat Panel Detectors (CareView 1800Cwe /CareView 1500Cwe) is manufactured by Careray Digital Medical System Co., Ltd..

What is the FDA product code for X-ray Flat Panel Detectors (CareView 1800Cwe /CareView 1500Cwe)?

The FDA product code for X-ray Flat Panel Detectors (CareView 1800Cwe /CareView 1500Cwe) is MQB.

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

K163019CareView 750Cw/750C X-ray Flat Panel Detectors K162178CareView 1500P X-ray Flat Panel Detectors K172581CareView 1800Cw X-ray Flat Panel Detectors K193173CareView 1800Le 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 K163019CareView 750Cw/750C X-ray Flat Panel DetectorsCareray Digital Medical System Co., Ltd. K160143ClearVision ExamVue Flat Panel DetectorJpi Healthcare, 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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