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FDA 510(k)

Quantitative Total Extensible Imaging (QTxI)

K-Number: K173444 · 2018-07-23

ApplicantAiq Solutions, Inc.
Decision Date2018-07-23
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Quantitative Total Extensible Imaging (QTxI) is the device name listed in this FDA 510(k) record. The listed applicant is Aiq Solutions, Inc.. It received FDA 510(k) clearance on 2018-07-23 under 510(k) number K173444. 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 Quantitative Total Extensible Imaging (QTxI)?

Quantitative Total Extensible Imaging (QTxI) is a medical device that received FDA 510(k) clearance on 2018-07-23. The listed applicant is Aiq Solutions, Inc.. The 510(k) number is K173444.

When did Quantitative Total Extensible Imaging (QTxI) receive FDA 510(k) clearance?

Quantitative Total Extensible Imaging (QTxI) received FDA 510(k) clearance on 2018-07-23, under 510(k) number K173444.

Who is the listed applicant for Quantitative Total Extensible Imaging (QTxI)?

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

What is the FDA product code for Quantitative Total Extensible Imaging (QTxI)?

The FDA product code for Quantitative Total Extensible Imaging (QTxI) 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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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