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FDA 510(k)

CareView 1800Le

K-Number: K193173 · 2019-12-13

ApplicantCareray Digital Medical System Co., Ltd.
Decision Date2019-12-13
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CareView 1800Le is the device name listed in this FDA 510(k) record. The listed applicant is Careray Digital Medical System Co., Ltd.. It received FDA 510(k) clearance on 2019-12-13 under 510(k) number K193173. 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 1800Le?

CareView 1800Le is a medical device that received FDA 510(k) clearance on 2019-12-13. The listed applicant is Careray Digital Medical System Co., Ltd.. The 510(k) number is K193173.

When did CareView 1800Le receive FDA 510(k) clearance?

CareView 1800Le received FDA 510(k) clearance on 2019-12-13, under 510(k) number K193173.

Who is the listed applicant for CareView 1800Le?

The FDA 510(k) record lists Careray Digital Medical System Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CareView 1800Le?

The FDA product code for CareView 1800Le is MQB.

Other records listing Careray Digital Medical System Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K202995X-ray Flat Panel Detectors/CareView 3600RFK201932X-ray Flat Panel Detectors (CareView 1800Cwe /CareView 1500Cwe)K172581CareView 1800Cw X-ray Flat Panel DetectorsK163019CareView 750Cw/750C X-ray Flat Panel DetectorsK162178CareView 1500P X-ray Flat Panel Detectors

Related Devices (Code: MQB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K2538000909FCE, 0909FCE-HSRayence Co., Ltd.K260820VIVIX-S 4386W (FXRD-4386WA)Vieworks Co., Ltd.K252996Universal 1417PIKonica Minolta Healthcare Americas, Inc.K252911Lux HD 2530 detector (Lux HD 2530)Iray Imaging Technology (Haining) LimitedK250211Yushan X-Ray Flat Panel DetectorInnocare Optoelectronics Corp.K250665SKR 3000Konica Minolta, 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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