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FDA 510(k)

MINXRAY, MODEL HF120/60H POWERPLUS

K-Number: K040046 · 2004-02-02

ApplicantMinxray, Inc.
Decision Date2004-02-02
Product CodeIZL
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MINXRAY, MODEL HF120/60H POWERPLUS is the device name listed in this FDA 510(k) record. The listed applicant is Minxray, Inc.. It received FDA 510(k) clearance on 2004-02-02 under 510(k) number K040046. 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 MINXRAY, MODEL HF120/60H POWERPLUS?

MINXRAY, MODEL HF120/60H POWERPLUS is a medical device that received FDA 510(k) clearance on 2004-02-02. The listed applicant is Minxray, Inc.. The 510(k) number is K040046.

When did MINXRAY, MODEL HF120/60H POWERPLUS receive FDA 510(k) clearance?

MINXRAY, MODEL HF120/60H POWERPLUS received FDA 510(k) clearance on 2004-02-02, under 510(k) number K040046.

Who is the listed applicant for MINXRAY, MODEL HF120/60H POWERPLUS?

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 MINXRAY, MODEL HF120/60H POWERPLUS?

The FDA product code for MINXRAY, MODEL HF120/60H POWERPLUS is IZL.

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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.

K210479IMPACT and X-RangerK201575CMDR 2C (Multiple Models)K191451CMDR 2CW (Multiple models)K182207TR90BHK171353CMDR 2ST (Multiple Models), CMDR 2SPE (Multiple Models), IntegrisK153059HF1202H PowerPlus Portable X-ray Equipment

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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

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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