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FDA 510(k)

Hura CTP v1.0

K-Number: K212550 · 2021-11-08

ApplicantHura Imaging, Inc.
Decision Date2021-11-08
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Hura CTP v1.0 is the device name listed in this FDA 510(k) record. The listed applicant is Hura Imaging, Inc.. It received FDA 510(k) clearance on 2021-11-08 under 510(k) number K212550. 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 Hura CTP v1.0?

Hura CTP v1.0 is a medical device that received FDA 510(k) clearance on 2021-11-08. The listed applicant is Hura Imaging, Inc.. The 510(k) number is K212550.

When did Hura CTP v1.0 receive FDA 510(k) clearance?

Hura CTP v1.0 received FDA 510(k) clearance on 2021-11-08, under 510(k) number K212550.

Who is the listed applicant for Hura CTP v1.0?

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

What is the FDA product code for Hura CTP v1.0?

The FDA product code for Hura CTP v1.0 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, LLCK261916NeuroQuant PETCortechs Labs, Inc.K260936RadioViewAINeurocareai, Inc. (Dba Savelife.Ai)K260588Cleerly LABSCleerly, Inc.K262462TheraSphere 360™ Y-90 Management PlatformBoston Scientific CorporationK262143ImageGrid 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.

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