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FDA 510(k)

IMPACT and X-Ranger

K-Number: K210479 · 2021-03-19

ApplicantMinxray, Inc.
Decision Date2021-03-19
Product CodeIZL
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

IMPACT and X-Ranger is the device name listed in this FDA 510(k) record. The listed applicant is Minxray, Inc.. It received FDA 510(k) clearance on 2021-03-19 under 510(k) 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. The listed applicant is Minxray, Inc.. The 510(k) number is K210479.

When did IMPACT and X-Ranger receive FDA 510(k) clearance?

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

Who is the listed applicant for IMPACT and X-Ranger?

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 IMPACT and X-Ranger?

The FDA product code for IMPACT and X-Ranger 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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