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FDA 510(k)

CMDR 2CW (Multiple models)

K-Number: K191451 · 2019-07-03

ApplicantMinxray, Inc.
Decision Date2019-07-03
Product CodeIZL
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CMDR 2CW (Multiple models) is the device name listed in this FDA 510(k) record. The listed applicant is Minxray, Inc.. It received FDA 510(k) clearance on 2019-07-03 under 510(k) number K191451. The device is classified under product code IZL. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CMDR 2CW (Multiple models)?

CMDR 2CW (Multiple models) is a medical device that received FDA 510(k) clearance on 2019-07-03. The listed applicant is Minxray, Inc.. The 510(k) number is K191451.

When did CMDR 2CW (Multiple models) receive FDA 510(k) clearance?

CMDR 2CW (Multiple models) received FDA 510(k) clearance on 2019-07-03, under 510(k) number K191451.

Who is the listed applicant for CMDR 2CW (Multiple models)?

The FDA 510(k) record lists Minxray, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CMDR 2CW (Multiple models)?

The FDA product code for CMDR 2CW (Multiple models) is IZL.

Other records listing Minxray, Inc. 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.

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Related Devices (Code: IZL)

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.

K260236XLITEGEMSS HEALTHCARE CO., LTD.K253058Portable DR Imaging SystemShantou Institute of Ultrasonic Instruments Co., Ltd.K260085RAYMO Mobile X-ray System (Model: RAYMO)DRGEM CorporationK253185Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray SystemCarestream HealthK253244AirRay-mini 80A, AirRay-mini 90A, AirRay-mini 80F, AirRay-mini 90F (AirRay-mini)Poskom Co., Ltd.K250976Airbile-100Poskom Co., Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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