FDA 510(k)

IMPACT and X-Ranger

K-Number: K210479 · 2021-03-19

Decision Date2021-03-19

Product CodeIZL

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

IMPACT and X-Ranger is a medical device manufactured by Minxray, Inc.. It received FDA 510(k) clearance on 2021-03-19 under approval number K210479. 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 IMPACT and X-Ranger?

IMPACT and X-Ranger is a medical device that received FDA 510(k) clearance on 2021-03-19. It is manufactured by Minxray, Inc.. The 510(k) number is K210479.

When was IMPACT and X-Ranger approved by the FDA?

IMPACT and X-Ranger received FDA 510(k) clearance on 2021-03-19, under approval number K210479.

What company makes IMPACT and X-Ranger?

IMPACT and X-Ranger is manufactured by Minxray, Inc..

What is the FDA product code for IMPACT and X-Ranger?

The FDA product code for IMPACT and X-Ranger is IZL.

Other Devices by Minxray, Inc.

K153059HF1202H PowerPlus Portable X-ray Equipment K171353CMDR 2ST (Multiple Models), CMDR 2SPE (Multiple Models), Integris K182207TR90BH K191451CMDR 2CW (Multiple models) K201575CMDR 2C (Multiple Models)

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.