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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 a medical device manufactured by Volpara Health Technologies Limited. It received FDA 510(k) clearance on 2021-07-27 under approval 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. It is manufactured by Volpara Health Technologies Limited. The 510(k) number is K211279.

When was Volpara Imaging Software approved by the FDA?

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

What company makes Volpara Imaging Software?

Volpara Imaging Software is manufactured by Volpara Health Technologies Limited.

What is the FDA product code for Volpara Imaging Software?

The FDA product code for Volpara Imaging Software is LLZ.

Related Clinical Trials

NCT03331380 Technical Development of Cardiovascular Magnetic Resonance Imaging (CMR) Using a Low Specific Absorption Rate (SAR) Scanner System RECRUITING NCT01621594 Evaluating New Radiation Techniques for Cardiovascular Imaging RECRUITING NCT02091518 Development and Evaluation of Magnetic Resonance Imaging Acquisition and Analysis Methods ENROLLING_BY_INVITATION NCT07580105 Clinical Study to Assess the Safety and Performance of Kenko Breast AI+ Medical Device as an Aid to Breast Cancer Diagnosis in Adult Women NOT_YET_RECRUITING NCT07226869 Computer Guided Microwave Liver Ablation RECRUITING NCT04975139 Cognitive Changes of IDH-mutant and IDH-wildtype Glioma Patients After Chemoradiotherapy With Radiation Dose to the Resting State Networks ACTIVE_NOT_RECRUITING

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)

Other Devices by Volpara Health Technologies Limited

K182310Volpara Imaging Software

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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.

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