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FDA 510(k)

Radiomics App v1.0

K-Number: K173420 · 2017-12-27

ApplicantMicrosoft Corp.
Decision Date2017-12-27
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Radiomics App v1.0 is the device name listed in this FDA 510(k) record. The listed applicant is Microsoft Corp.. It received FDA 510(k) clearance on 2017-12-27 under 510(k) number K173420. 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 Radiomics App v1.0?

Radiomics App v1.0 is a medical device that received FDA 510(k) clearance on 2017-12-27. The listed applicant is Microsoft Corp.. The 510(k) number is K173420.

When did Radiomics App v1.0 receive FDA 510(k) clearance?

Radiomics App v1.0 received FDA 510(k) clearance on 2017-12-27, under 510(k) number K173420.

Who is the listed applicant for Radiomics App v1.0?

The FDA 510(k) record lists Microsoft Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Radiomics App v1.0?

The FDA product code for Radiomics App 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

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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