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FDA 510(k)

Volpara Imaging Software

K-Number: K211279 · 2021-07-27

ApplicantVolpara Health Technologies Limited
Decision Date2021-07-27
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Volpara Imaging Software is the device name listed in this FDA 510(k) record. The listed applicant is Volpara Health Technologies Limited. It received FDA 510(k) clearance on 2021-07-27 under 510(k) number K211279. 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 Volpara Imaging Software?

Volpara Imaging Software is a medical device that received FDA 510(k) clearance on 2021-07-27. The listed applicant is Volpara Health Technologies Limited. The 510(k) number is K211279.

When did Volpara Imaging Software receive FDA 510(k) clearance?

Volpara Imaging Software received FDA 510(k) clearance on 2021-07-27, under 510(k) number K211279.

Who is the listed applicant for Volpara Imaging Software?

The FDA 510(k) record lists Volpara Health Technologies Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Volpara Imaging Software?

The FDA product code for Volpara Imaging Software is LLZ.

Other records listing Volpara Health Technologies Limited as applicant

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.

K182310Volpara Imaging Software

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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