FDA 510(k)

Volpara Imaging Software

K-Number: K153427 · 2016-01-07

Decision Date2016-01-07

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 Matakina Technology, Ltd.. It received FDA 510(k) clearance on 2016-01-07 under 510(k) number K153427. 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 2016-01-07. The listed applicant is Matakina Technology, Ltd.. The 510(k) number is K153427.

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

Volpara Imaging Software received FDA 510(k) clearance on 2016-01-07, under 510(k) number K153427.

Who is the listed applicant for Volpara Imaging Software?

The FDA 510(k) record lists Matakina Technology, Ltd. 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.

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.

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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.