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FDA 510(k)

FlexView Diagnostic (v1.1.20)

K-Number: K233226 · 2024-01-17

ApplicantRadical Imaging, LLC
Decision Date2024-01-17
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

FlexView Diagnostic (v1.1.20) is the device name listed in this FDA 510(k) record. The listed applicant is Radical Imaging, LLC. It received FDA 510(k) clearance on 2024-01-17 under 510(k) number K233226. 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 FlexView Diagnostic (v1.1.20)?

FlexView Diagnostic (v1.1.20) is a medical device that received FDA 510(k) clearance on 2024-01-17. The listed applicant is Radical Imaging, LLC. The 510(k) number is K233226.

When did FlexView Diagnostic (v1.1.20) receive FDA 510(k) clearance?

FlexView Diagnostic (v1.1.20) received FDA 510(k) clearance on 2024-01-17, under 510(k) number K233226.

Who is the listed applicant for FlexView Diagnostic (v1.1.20)?

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

What is the FDA product code for FlexView Diagnostic (v1.1.20)?

The FDA product code for FlexView Diagnostic (v1.1.20) 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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