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FDA 510(k)

APX-24 Portable X-ray System

K-Number: K220678 · 2022-03-31

ApplicantAspenstate, Inc.
Decision Date2022-03-31
Product CodeIZL
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

APX-24 Portable X-ray System is a medical device manufactured by Aspenstate, Inc.. It received FDA 510(k) clearance on 2022-03-31 under approval number K220678. 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 APX-24 Portable X-ray System?

APX-24 Portable X-ray System is a medical device that received FDA 510(k) clearance on 2022-03-31. It is manufactured by Aspenstate, Inc.. The 510(k) number is K220678.

When was APX-24 Portable X-ray System approved by the FDA?

APX-24 Portable X-ray System received FDA 510(k) clearance on 2022-03-31, under approval number K220678.

What company makes APX-24 Portable X-ray System?

APX-24 Portable X-ray System is manufactured by Aspenstate, Inc..

What is the FDA product code for APX-24 Portable X-ray System?

The FDA product code for APX-24 Portable X-ray System is IZL.

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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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