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FDA 510(k)

HF1202H PowerPlus Portable X-ray Equipment

K-Number: K153059 · 2016-02-02

ApplicantMinxray, Inc.
Decision Date2016-02-02
Product CodeIZL
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

HF1202H PowerPlus Portable X-ray Equipment is a medical device manufactured by Minxray, Inc.. It received FDA 510(k) clearance on 2016-02-02 under approval number K153059. 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 HF1202H PowerPlus Portable X-ray Equipment?

HF1202H PowerPlus Portable X-ray Equipment is a medical device that received FDA 510(k) clearance on 2016-02-02. It is manufactured by Minxray, Inc.. The 510(k) number is K153059.

When was HF1202H PowerPlus Portable X-ray Equipment approved by the FDA?

HF1202H PowerPlus Portable X-ray Equipment received FDA 510(k) clearance on 2016-02-02, under approval number K153059.

What company makes HF1202H PowerPlus Portable X-ray Equipment?

HF1202H PowerPlus Portable X-ray Equipment is manufactured by Minxray, Inc..

What is the FDA product code for HF1202H PowerPlus Portable X-ray Equipment?

The FDA product code for HF1202H PowerPlus Portable X-ray Equipment is IZL.

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Other Devices by Minxray, Inc.

K171353CMDR 2ST (Multiple Models), CMDR 2SPE (Multiple Models), Integris K182207TR90BH K191451CMDR 2CW (Multiple models) 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. K173018MDR17 Mobile Direct Radiographic SystemDel Medical, 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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