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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 a medical device manufactured by Minxray, Inc.. It received FDA 510(k) clearance on 2019-07-03 under approval 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. It is manufactured by Minxray, Inc.. The 510(k) number is K191451.

When was CMDR 2CW (Multiple models) approved by the FDA?

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

What company makes CMDR 2CW (Multiple models)?

CMDR 2CW (Multiple models) is manufactured by Minxray, Inc..

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

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

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Other Devices by Minxray, Inc.

K153059HF1202H PowerPlus Portable X-ray Equipment K171353CMDR 2ST (Multiple Models), CMDR 2SPE (Multiple Models), Integris K182207TR90BH K201575CMDR 2C (Multiple Models) K210479IMPACT and X-Ranger

Related Devices (Code: IZL)

K163063UC-5000 Mobile X-RaySource-Ray, Inc. K162990Optima XR240amxGe Medical Systems, LLC K162278Digital Diagnostic Mobile X-ray SystemSamsung Electronics Co., Ltd. K162687Paragon 2Meridian Medical Systems, LLC K161345RadPRO® Mobile 40kW; RadPRO® Mobile 40kW FLEXPLUS, Model SM-40HF-B-D-VIRSedecal., Sa. K153059HF1202H PowerPlus Portable X-ray EquipmentMinxray, Inc.

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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