FDA 510(k)

OrionXR

K-Number: K232189 · 2023-09-14

Decision Date2023-09-14

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

OrionXR is the device name listed in this FDA 510(k) record. The listed applicant is Hoth Intelligence, Inc.. It received FDA 510(k) clearance on 2023-09-14 under 510(k) number K232189. 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 OrionXR?

OrionXR is a medical device that received FDA 510(k) clearance on 2023-09-14. The listed applicant is Hoth Intelligence, Inc.. The 510(k) number is K232189.

When did OrionXR receive FDA 510(k) clearance?

OrionXR received FDA 510(k) clearance on 2023-09-14, under 510(k) number K232189.

Who is the listed applicant for OrionXR?

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

What is the FDA product code for OrionXR?

The FDA product code for OrionXR is LLZ.

Related Devices (Code: LLZ)

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.

K262449AdvaViewADVAHEALTH SOLUTIONS, LLC K261916NeuroQuant PETCortechs Labs, Inc.K260936RadioViewAINeurocareai, Inc. (Dba Savelife.Ai)K260588Cleerly LABSCleerly, Inc.K262462TheraSphere 360™ Y-90 Management PlatformBoston Scientific Corporation K262143ImageGrid StreamVueCandelis, Inc.

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.