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FDA 510(k)

Dynamyx Digital Pathology Software

K-Number: K210811 · 2022-03-01

ApplicantInspirata, Inc.
Decision Date2022-03-01
Product CodeQKQ
Advisory CommitteePA
DecisionSubstantially Equivalent

Device Summary

Dynamyx Digital Pathology Software is a medical device manufactured by Inspirata, Inc.. It received FDA 510(k) clearance on 2022-03-01 under approval number K210811. The device is classified under product code QKQ. It was reviewed by the PA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Dynamyx Digital Pathology Software?

Dynamyx Digital Pathology Software is a medical device that received FDA 510(k) clearance on 2022-03-01. It is manufactured by Inspirata, Inc.. The 510(k) number is K210811.

When was Dynamyx Digital Pathology Software approved by the FDA?

Dynamyx Digital Pathology Software received FDA 510(k) clearance on 2022-03-01, under approval number K210811.

What company makes Dynamyx Digital Pathology Software?

Dynamyx Digital Pathology Software is manufactured by Inspirata, Inc..

What is the FDA product code for Dynamyx Digital Pathology Software?

The FDA product code for Dynamyx Digital Pathology Software is QKQ.

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Related PubMed Literature

PMID: 42174919 Automating Safety Surveillance for Software-Based Medical Devices: Insights from FDA MAUDE Data. Studies in health technology and informatics (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: 41844911 Toward global standards for SaMD: introducing a proposal for Good Digital Medicine Practices (GDMP). NPJ digital medicine (2026) PMID: 41513582 Medical devices for professional use: What assessment, what funding? Therapie (2026)

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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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