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FDA 510(k)

MetaLite DX Digital Pathology Software

K-Number: K240303 · 2024-10-28

ApplicantJellox Biotech, Inc.
Decision Date2024-10-28
Product CodeQKQ
Advisory CommitteePA
DecisionSubstantially Equivalent

Device Summary

MetaLite DX Digital Pathology Software is a medical device manufactured by Jellox Biotech, Inc.. It received FDA 510(k) clearance on 2024-10-28 under approval number K240303. 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 MetaLite DX Digital Pathology Software?

MetaLite DX Digital Pathology Software is a medical device that received FDA 510(k) clearance on 2024-10-28. It is manufactured by Jellox Biotech, Inc.. The 510(k) number is K240303.

When was MetaLite DX Digital Pathology Software approved by the FDA?

MetaLite DX Digital Pathology Software received FDA 510(k) clearance on 2024-10-28, under approval number K240303.

What company makes MetaLite DX Digital Pathology Software?

MetaLite DX Digital Pathology Software is manufactured by Jellox Biotech, Inc..

What is the FDA product code for MetaLite DX Digital Pathology Software?

The FDA product code for MetaLite DX 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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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