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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 the device name listed in this FDA 510(k) record. The listed applicant is Minxray, Inc.. It received FDA 510(k) clearance on 2016-02-02 under 510(k) 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. The listed applicant is Minxray, Inc.. The 510(k) number is K153059.

When did HF1202H PowerPlus Portable X-ray Equipment receive FDA 510(k) clearance?

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

Who is the listed applicant for HF1202H PowerPlus Portable X-ray Equipment?

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 HF1202H PowerPlus Portable X-ray Equipment?

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

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.

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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.

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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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