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FDA 510(k)

Volpara Imaging Software

K-Number: K153427 · 2016-01-07

ApplicantMatakina Technology, Ltd.
Decision Date2016-01-07
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Volpara Imaging Software is a medical device manufactured by Matakina Technology, Ltd.. It received FDA 510(k) clearance on 2016-01-07 under approval 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. It is manufactured by Matakina Technology, Ltd.. The 510(k) number is K153427.

When was Volpara Imaging Software approved by the FDA?

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

What company makes Volpara Imaging Software?

Volpara Imaging Software is manufactured by Matakina Technology, Ltd..

What is the FDA product code for Volpara Imaging Software?

The FDA product code for Volpara Imaging Software is LLZ.

Related Clinical Trials

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Related PubMed Literature

PMID: 41938602 AI-enabled cardiovascular devices: a lifecycle playbook for evidence, change control, and post-market assurance. Frontiers in digital health (2026) PMID: 41883556 A clinician's quick‑start guide to implementing digital health innovations in the NHS - with lessons from a UK-deployed AI stroke imaging decision-support software. Digital health (2026) PMID: 41476571 Digital pathology imaging artificial intelligence in cancer research and clinical trials: An NCI workshop report. Journal of pathology informatics (2026)

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Official Source

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