FDA 510(k)

AXIR-CX

K-Number: K213520 · 2022-08-19

Decision Date2022-08-19

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

AXIR-CX is the device name listed in this FDA 510(k) record. The listed applicant is Radisen Co., Ltd.. It received FDA 510(k) clearance on 2022-08-19 under 510(k) number K213520. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AXIR-CX?

AXIR-CX is a medical device that received FDA 510(k) clearance on 2022-08-19. The listed applicant is Radisen Co., Ltd.. The 510(k) number is K213520.

When did AXIR-CX receive FDA 510(k) clearance?

AXIR-CX received FDA 510(k) clearance on 2022-08-19, under 510(k) number K213520.

Who is the listed applicant for AXIR-CX?

The FDA 510(k) record lists Radisen Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AXIR-CX?

The FDA product code for AXIR-CX is LLZ.

Other records listing Radisen Co., Ltd. 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.

K221144PEDRA-1417MC, PEDRA-1417MG, PEDRA-1417FC, PEDRA-1417FG K180989PEDRA-17F Digital Flat Panel X-ray Detector

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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.