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FDA 510(k)

TR90BH

K-Number: K182207 · 2018-12-14

ApplicantMinxray, Inc.
Decision Date2018-12-14
Product CodeIZL
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

TR90BH is a medical device manufactured by Minxray, Inc.. It received FDA 510(k) clearance on 2018-12-14 under approval number K182207. 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 TR90BH?

TR90BH is a medical device that received FDA 510(k) clearance on 2018-12-14. It is manufactured by Minxray, Inc.. The 510(k) number is K182207.

When was TR90BH approved by the FDA?

TR90BH received FDA 510(k) clearance on 2018-12-14, under approval number K182207.

What company makes TR90BH?

TR90BH is manufactured by Minxray, Inc..

What is the FDA product code for TR90BH?

The FDA product code for TR90BH is IZL.

Other Devices by Minxray, Inc.

K153059HF1202H PowerPlus Portable X-ray Equipment K171353CMDR 2ST (Multiple Models), CMDR 2SPE (Multiple Models), Integris 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. K153059HF1202H PowerPlus Portable X-ray EquipmentMinxray, 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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