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FDA 510(k)

MXR-2000 MOBILE X-RAY UNIT

K-Number: K010304 · 2001-02-12

ApplicantIrom Imaging, Inc.
Decision Date2001-02-12
Product CodeIZL
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MXR-2000 MOBILE X-RAY UNIT is the device name listed in this FDA 510(k) record. The listed applicant is Irom Imaging, Inc.. It received FDA 510(k) clearance on 2001-02-12 under 510(k) number K010304. 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 MXR-2000 MOBILE X-RAY UNIT?

MXR-2000 MOBILE X-RAY UNIT is a medical device that received FDA 510(k) clearance on 2001-02-12. The listed applicant is Irom Imaging, Inc.. The 510(k) number is K010304.

When did MXR-2000 MOBILE X-RAY UNIT receive FDA 510(k) clearance?

MXR-2000 MOBILE X-RAY UNIT received FDA 510(k) clearance on 2001-02-12, under 510(k) number K010304.

Who is the listed applicant for MXR-2000 MOBILE X-RAY UNIT?

The FDA 510(k) record lists Irom Imaging, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MXR-2000 MOBILE X-RAY UNIT?

The FDA product code for MXR-2000 MOBILE X-RAY UNIT is IZL.

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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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